Sun Pharmaceutical Industries Limited Discontinued
FDA Approved Drugs

Sun Pharmaceutical Industries Limited Discontinued

FDA Approved Drugs Database

FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.

Discontinued
  • Total Records 698
  • Latest Approval Date Jul 01, 2024
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
1031
View
Unclassified
41
View
Discontinued
698
View
OTC
21
View
RX
271
View
Company Overview

Company

Sun Pharmaceutical Industries Limited Discontinued

Country

India

Website

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Company Snapshot

Sun Pharmaceutical Industries Limited Discontinued

Sun House, CTS No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063

India

sunpharma.com/ View on Map
FDA Approved Drug Records ( 698 records )
2019
05 Nov
Discontinued Application: 211913

Drug Name

ABSORICA LD

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2019-11-05

211913 / 3

Active Ingredient

ISOTRETINOIN

Application Number

211913

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2019-11-05

Regulatory Status

Discontinued

2019
05 Nov
Discontinued Application: 211913

Drug Name

ABSORICA LD

Product Number

5

Dosage Form

-

Strength

28MG

Approval Date

2019-11-05

211913 / 5

Active Ingredient

ISOTRETINOIN

Application Number

211913

Product Number

5

Dosage Form

-

Strength

28MG

Approval Date

2019-11-05

Regulatory Status

Discontinued

1995
27 Feb
Discontinued Application: 73106

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

1995-02-27

73106 / 1

Active Ingredient

ACETAMINOPHEN

Application Number

73106

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

1995-02-27

Regulatory Status

Discontinued

1995
27 Feb
Discontinued Application: 73107

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG

Approval Date

1995-02-27

73107 / 1

Active Ingredient

ACETAMINOPHEN

Application Number

73107

Product Number

1

Dosage Form

-

Strength

325MG

Approval Date

1995-02-27

Regulatory Status

Discontinued

1995
27 Feb
Discontinued Application: 73108

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

1995-02-27

73108 / 1

Active Ingredient

ACETAMINOPHEN

Application Number

73108

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

1995-02-27

Regulatory Status

Discontinued

2011
14 Dec
Discontinued Application: 78569

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

2011-12-14

78569 / 1

Active Ingredient

ACETAMINOPHEN

Application Number

78569

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

2011-12-14

Regulatory Status

Discontinued

2009
18 Nov
Discontinued Application: 90205

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

2009-11-18

90205 / 1

Active Ingredient

ACETAMINOPHEN

Application Number

90205

Product Number

1

Dosage Form

-

Strength

650MG

Approval Date

2009-11-18

Regulatory Status

Discontinued

2002
01 Aug
Discontinued Application: 40452

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

2002-08-01

40452 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

40452

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

2002-08-01

Regulatory Status

Discontinued

2002
01 Aug
Discontinued Application: 40459

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

2002-08-01

40459 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

40459

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

2002-08-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85868

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

1982-01-01

85868 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

85868

Product Number

1

Dosage Form

-

Strength

300MG;30MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1998
30 Sep
Discontinued Application: 74980

Drug Name

ACYCLOVIR

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1998-09-30

74980 / 1

Active Ingredient

ACYCLOVIR

Application Number

74980

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

1998-09-30

Regulatory Status

Discontinued

1998
30 Sep
Discontinued Application: 74980

Drug Name

ACYCLOVIR

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

1998-09-30

74980 / 2

Active Ingredient

ACYCLOVIR

Application Number

74980

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

1998-09-30

Regulatory Status

Discontinued

2011
18 Jul
Discontinued Application: 79057

Drug Name

ALFUZOSIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2011-07-18

79057 / 1

Active Ingredient

ALFUZOSIN HYDROCHLORIDE

Application Number

79057

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2011-07-18

Regulatory Status

Discontinued

2007
30 Aug
Discontinued Application: 78390

Drug Name

ALLOPURINOL

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2007-08-30

78390 / 1

Active Ingredient

ALLOPURINOL

Application Number

78390

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2007-08-30

Regulatory Status

Discontinued

2007
30 Aug
Discontinued Application: 78390

Drug Name

ALLOPURINOL

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2007-08-30

78390 / 2

Active Ingredient

ALLOPURINOL

Application Number

78390

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2007-08-30

Regulatory Status

Discontinued

2010
17 Jun
Discontinued Application: 90082

Drug Name

ALPRAZOLAM

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2010-06-17

90082 / 1

Active Ingredient

ALPRAZOLAM

Application Number

90082

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2010-06-17

Regulatory Status

Discontinued

2010
17 Jun
Discontinued Application: 90082

Drug Name

ALPRAZOLAM

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2010-06-17

90082 / 2

Active Ingredient

ALPRAZOLAM

Application Number

90082

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2010-06-17

Regulatory Status

Discontinued

2010
17 Jun
Discontinued Application: 90082

Drug Name

ALPRAZOLAM

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2010-06-17

90082 / 3

Active Ingredient

ALPRAZOLAM

Application Number

90082

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2010-06-17

Regulatory Status

Discontinued

2010
17 Jun
Discontinued Application: 90082

Drug Name

ALPRAZOLAM

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2010-06-17

90082 / 4

Active Ingredient

ALPRAZOLAM

Application Number

90082

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2010-06-17

Regulatory Status

Discontinued

2019
28 Mar
Discontinued Application: 210784

Drug Name

AMBRISENTAN

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-03-28

210784 / 1

Active Ingredient

AMBRISENTAN

Application Number

210784

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-03-28

Regulatory Status

Discontinued

2019
28 Mar
Discontinued Application: 210784

Drug Name

AMBRISENTAN

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-03-28

210784 / 2

Active Ingredient

AMBRISENTAN

Application Number

210784

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-03-28

Regulatory Status

Discontinued

2008
14 Mar
Discontinued Application: 77126

Drug Name

AMIFOSTINE

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2008-03-14

77126 / 1

Active Ingredient

AMIFOSTINE

Application Number

77126

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2008-03-14

Regulatory Status

Discontinued

2008
27 Jun
Discontinued Application: 40816

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2008-06-27

40816 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

40816

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2008-06-27

Regulatory Status

Discontinued

2008
27 Jun
Discontinued Application: 40816

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2008-06-27

40816 / 2

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

40816

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2008-06-27

Regulatory Status

Discontinued

2008
27 Jun
Discontinued Application: 40816

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2008-06-27

40816 / 3

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

40816

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2008-06-27

Regulatory Status

Discontinued

2008
27 Jun
Discontinued Application: 40816

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

75MG

Approval Date

2008-06-27

40816 / 4

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

40816

Product Number

4

Dosage Form

-

Strength

75MG

Approval Date

2008-06-27

Regulatory Status

Discontinued

2008
27 Jun
Discontinued Application: 40816

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

100MG

Approval Date

2008-06-27

40816 / 5

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

40816

Product Number

5

Dosage Form

-

Strength

100MG

Approval Date

2008-06-27

Regulatory Status

Discontinued

2008
27 Jun
Discontinued Application: 40816

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

150MG

Approval Date

2008-06-27

40816 / 6

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

40816

Product Number

6

Dosage Form

-

Strength

150MG

Approval Date

2008-06-27

Regulatory Status

Discontinued

2007
09 Jul
Discontinued Application: 77974

Drug Name

AMLODIPINE BESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2007-07-09

77974 / 1

Active Ingredient

AMLODIPINE BESYLATE

Application Number

77974

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2007-07-09

Regulatory Status

Discontinued

2007
09 Jul
Discontinued Application: 77974

Drug Name

AMLODIPINE BESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2007-07-09

77974 / 2

Active Ingredient

AMLODIPINE BESYLATE

Application Number

77974

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2007-07-09

Regulatory Status

Discontinued

2007
09 Jul
Discontinued Application: 77974

Drug Name

AMLODIPINE BESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-07-09

77974 / 3

Active Ingredient

AMLODIPINE BESYLATE

Application Number

77974

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-07-09

Regulatory Status

Discontinued

2007
30 Nov
Discontinued Application: 78231

Drug Name

AMLODIPINE BESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2007-11-30

78231 / 1

Active Ingredient

AMLODIPINE BESYLATE

Application Number

78231

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2007-11-30

Regulatory Status

Discontinued

2007
30 Nov
Discontinued Application: 78231

Drug Name

AMLODIPINE BESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2007-11-30

78231 / 2

Active Ingredient

AMLODIPINE BESYLATE

Application Number

78231

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2007-11-30

Regulatory Status

Discontinued

2007
30 Nov
Discontinued Application: 78231

Drug Name

AMLODIPINE BESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-11-30

78231 / 3

Active Ingredient

AMLODIPINE BESYLATE

Application Number

78231

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-11-30

Regulatory Status

Discontinued

1999
08 Apr
Discontinued Application: 65016

Drug Name

AMOXICILLIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1999-04-08

65016 / 1

Active Ingredient

AMOXICILLIN

Application Number

65016

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1999-04-08

Regulatory Status

Discontinued

1999
08 Apr
Discontinued Application: 65016

Drug Name

AMOXICILLIN

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1999-04-08

65016 / 2

Active Ingredient

AMOXICILLIN

Application Number

65016

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

1999-04-08

Regulatory Status

Discontinued

1999
23 Dec
Discontinued Application: 65021

Drug Name

AMOXICILLIN

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

1999-12-23

65021 / 1

Active Ingredient

AMOXICILLIN

Application Number

65021

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

1999-12-23

Regulatory Status

Discontinued

1999
23 Dec
Discontinued Application: 65021

Drug Name

AMOXICILLIN

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

1999-12-23

65021 / 2

Active Ingredient

AMOXICILLIN

Application Number

65021

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

1999-12-23

Regulatory Status

Discontinued

2000
24 Nov
Discontinued Application: 65059

Drug Name

AMOXICILLIN

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2000-11-24

65059 / 1

Active Ingredient

AMOXICILLIN

Application Number

65059

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2000-11-24

Regulatory Status

Discontinued

2000
24 Nov
Discontinued Application: 65059

Drug Name

AMOXICILLIN

Product Number

2

Dosage Form

-

Strength

875MG

Approval Date

2000-11-24

65059 / 2

Active Ingredient

AMOXICILLIN

Application Number

65059

Product Number

2

Dosage Form

-

Strength

875MG

Approval Date

2000-11-24

Regulatory Status

Discontinued

2000
29 Nov
Discontinued Application: 65060

Drug Name

AMOXICILLIN

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2000-11-29

65060 / 1

Active Ingredient

AMOXICILLIN

Application Number

65060

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2000-11-29

Regulatory Status

Discontinued

2000
29 Nov
Discontinued Application: 65060

Drug Name

AMOXICILLIN

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

2000-11-29

65060 / 2

Active Ingredient

AMOXICILLIN

Application Number

65060

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

2000-11-29

Regulatory Status

Discontinued

2002
29 Nov
Discontinued Application: 65113

Drug Name

AMOXICILLIN

Product Number

1

Dosage Form

-

Strength

200MG/5ML

Approval Date

2002-11-29

65113 / 1

Active Ingredient

AMOXICILLIN

Application Number

65113

Product Number

1

Dosage Form

-

Strength

200MG/5ML

Approval Date

2002-11-29

Regulatory Status

Discontinued

2002
29 Nov
Discontinued Application: 65113

Drug Name

AMOXICILLIN

Product Number

2

Dosage Form

-

Strength

400MG/5ML

Approval Date

2002-11-29

65113 / 2

Active Ingredient

AMOXICILLIN

Application Number

65113

Product Number

2

Dosage Form

-

Strength

400MG/5ML

Approval Date

2002-11-29

Regulatory Status

Discontinued

2002
17 Sep
Discontinued Application: 65102

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

1

Dosage Form

-

Strength

875MG;EQ 125MG BASE

Approval Date

2002-09-17

65102 / 1

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

65102

Product Number

1

Dosage Form

-

Strength

875MG;EQ 125MG BASE

Approval Date

2002-09-17

Regulatory Status

Discontinued

2002
04 Nov
Discontinued Application: 65109

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

1

Dosage Form

-

Strength

500MG;EQ 125MG BASE

Approval Date

2002-11-04

65109 / 1

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

65109

Product Number

1

Dosage Form

-

Strength

500MG;EQ 125MG BASE

Approval Date

2002-11-04

Regulatory Status

Discontinued

2003
19 Mar
Discontinued Application: 65132

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

1

Dosage Form

-

Strength

200MG/5ML;EQ 28.5MG BASE/5ML

Approval Date

2003-03-19

65132 / 1

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

65132

Product Number

1

Dosage Form

-

Strength

200MG/5ML;EQ 28.5MG BASE/5ML

Approval Date

2003-03-19

Regulatory Status

Discontinued

2003
19 Mar
Discontinued Application: 65132

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

2

Dosage Form

-

Strength

400MG/5ML;EQ 57MG BASE/5ML

Approval Date

2003-03-19

65132 / 2

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

65132

Product Number

2

Dosage Form

-

Strength

400MG/5ML;EQ 57MG BASE/5ML

Approval Date

2003-03-19

Regulatory Status

Discontinued

2003
03 Dec
Discontinued Application: 65161

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

1

Dosage Form

-

Strength

200MG;EQ 28.5MG BASE

Approval Date

2003-12-03

65161 / 1

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

65161

Product Number

1

Dosage Form

-

Strength

200MG;EQ 28.5MG BASE

Approval Date

2003-12-03

Regulatory Status

Discontinued

2003
03 Dec
Discontinued Application: 65161

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

2

Dosage Form

-

Strength

400MG;EQ 57MG BASE

Approval Date

2003-12-03

65161 / 2

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

65161

Product Number

2

Dosage Form

-

Strength

400MG;EQ 57MG BASE

Approval Date

2003-12-03

Regulatory Status

Discontinued

2007
30 Jan
Discontinued Application: 65207

Drug Name

AMOXICILLIN AND CLAVULANATE POTASSIUM

Product Number

2

Dosage Form

-

Strength

600MG/5ML;EQ 42.9MG BASE/5ML

Approval Date

2007-01-30

65207 / 2

Active Ingredient

AMOXICILLIN; CLAVULANATE POTASSIUM

Application Number

65207

Product Number

2

Dosage Form

-

Strength

600MG/5ML;EQ 42.9MG BASE/5ML

Approval Date

2007-01-30

Regulatory Status

Discontinued

2021
27 Jan
Discontinued Application: 214574

Drug Name

AMPHETAMINE SULFATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2021-01-27

214574 / 1

Active Ingredient

AMPHETAMINE SULFATE

Application Number

214574

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2021-01-27

Regulatory Status

Discontinued

2021
27 Jan
Discontinued Application: 214574

Drug Name

AMPHETAMINE SULFATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2021-01-27

214574 / 2

Active Ingredient

AMPHETAMINE SULFATE

Application Number

214574

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2021-01-27

Regulatory Status

Discontinued

2011
15 Jul
Discontinued Application: 91177

Drug Name

ANASTROZOLE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2011-07-15

91177 / 1

Active Ingredient

ANASTROZOLE

Application Number

91177

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2011-07-15

Regulatory Status

Discontinued

2018
21 Aug
Discontinued Application: 208572

Drug Name

ASPIRIN AND DIPYRIDAMOLE

Product Number

1

Dosage Form

-

Strength

25MG;200MG

Approval Date

2018-08-21

208572 / 1

Active Ingredient

ASPIRIN; DIPYRIDAMOLE

Application Number

208572

Product Number

1

Dosage Form

-

Strength

25MG;200MG

Approval Date

2018-08-21

Regulatory Status

Discontinued

2004
30 Jul
Discontinued Application: 76907

Drug Name

ATENOLOL

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2004-07-30

76907 / 1

Active Ingredient

ATENOLOL

Application Number

76907

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2004-07-30

Regulatory Status

Discontinued

2004
30 Jul
Discontinued Application: 76907

Drug Name

ATENOLOL

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2004-07-30

76907 / 2

Active Ingredient

ATENOLOL

Application Number

76907

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2004-07-30

Regulatory Status

Discontinued

2004
30 Jul
Discontinued Application: 76907

Drug Name

ATENOLOL

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2004-07-30

76907 / 3

Active Ingredient

ATENOLOL

Application Number

76907

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2004-07-30

Regulatory Status

Discontinued

2007
10 Jul
Discontinued Application: 78210

Drug Name

ATENOLOL

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2007-07-10

78210 / 1

Active Ingredient

ATENOLOL

Application Number

78210

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2007-07-10

Regulatory Status

Discontinued

2007
10 Jul
Discontinued Application: 78210

Drug Name

ATENOLOL

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2007-07-10

78210 / 2

Active Ingredient

ATENOLOL

Application Number

78210

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2007-07-10

Regulatory Status

Discontinued

2007
10 Jul
Discontinued Application: 78210

Drug Name

ATENOLOL

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2007-07-10

78210 / 3

Active Ingredient

ATENOLOL

Application Number

78210

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2007-07-10

Regulatory Status

Discontinued

2011
30 Nov
Discontinued Application: 76477

Drug Name

ATORVASTATIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2011-11-30

76477 / 1

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

76477

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2011-11-30

Regulatory Status

Discontinued

2011
30 Nov
Discontinued Application: 76477

Drug Name

ATORVASTATIN CALCIUM

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2011-11-30

76477 / 2

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

76477

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2011-11-30

Regulatory Status

Discontinued

2011
30 Nov
Discontinued Application: 76477

Drug Name

ATORVASTATIN CALCIUM

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2011-11-30

76477 / 3

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

76477

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2011-11-30

Regulatory Status

Discontinued

2011
30 Nov
Discontinued Application: 76477

Drug Name

ATORVASTATIN CALCIUM

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2011-11-30

76477 / 4

Active Ingredient

ATORVASTATIN CALCIUM

Application Number

76477

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2011-11-30

Regulatory Status

Discontinued

2010
21 Jun
Discontinued Application: 78738

Drug Name

AZELASTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2010-06-21

78738 / 1

Active Ingredient

AZELASTINE HYDROCHLORIDE

Application Number

78738

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2010-06-21

Regulatory Status

Discontinued

2012
23 May
Discontinued Application: 90423

Drug Name

AZELASTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.137MG/SPRAY

Approval Date

2012-05-23

90423 / 1

Active Ingredient

AZELASTINE HYDROCHLORIDE

Application Number

90423

Product Number

1

Dosage Form

-

Strength

0.137MG/SPRAY

Approval Date

2012-05-23

Regulatory Status

Discontinued

2013
02 Apr
Discontinued Application: 90923

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2013-04-02

90923 / 1

Active Ingredient

AZITHROMYCIN

Application Number

90923

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2013-04-02

Regulatory Status

Discontinued

2006
14 Aug
Discontinued Application: 77862

Drug Name

BACLOFEN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2006-08-14

77862 / 1

Active Ingredient

BACLOFEN

Application Number

77862

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2006-08-14

Regulatory Status

Discontinued

2006
14 Aug
Discontinued Application: 77862

Drug Name

BACLOFEN

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2006-08-14

77862 / 2

Active Ingredient

BACLOFEN

Application Number

77862

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2006-08-14

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18374

Drug Name

BACTRIM

Product Number

1

Dosage Form

-

Strength

80MG/ML;16MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

18374 / 1

Active Ingredient

SULFAMETHOXAZOLE; TRIMETHOPRIM

Application Number

18374

Product Number

1

Dosage Form

-

Strength

80MG/ML;16MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

2005
08 Sep
Discontinued Application: 77483

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

5MG;6.25MG

Approval Date

2005-09-08

77483 / 1

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

77483

Product Number

1

Dosage Form

-

Strength

5MG;6.25MG

Approval Date

2005-09-08

Regulatory Status

Discontinued

2005
08 Sep
Discontinued Application: 77483

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

10MG;12.5MG

Approval Date

2005-09-08

77483 / 2

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

77483

Product Number

2

Dosage Form

-

Strength

10MG;12.5MG

Approval Date

2005-09-08

Regulatory Status

Discontinued

2005
08 Sep
Discontinued Application: 77483

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

20MG;12.5MG

Approval Date

2005-09-08

77483 / 3

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

77483

Product Number

3

Dosage Form

-

Strength

20MG;12.5MG

Approval Date

2005-09-08

Regulatory Status

Discontinued

2005
08 Sep
Discontinued Application: 77483

Drug Name

BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

4

Dosage Form

-

Strength

20MG;25MG

Approval Date

2005-09-08

77483 / 4

Active Ingredient

BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE

Application Number

77483

Product Number

4

Dosage Form

-

Strength

20MG;25MG

Approval Date

2005-09-08

Regulatory Status

Discontinued

2008
19 Mar
Discontinued Application: 40587

Drug Name

BENZONATATE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2008-03-19

40587 / 1

Active Ingredient

BENZONATATE

Application Number

40587

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2008-03-19

Regulatory Status

Discontinued

2008
19 Mar
Discontinued Application: 40587

Drug Name

BENZONATATE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2008-03-19

40587 / 2

Active Ingredient

BENZONATATE

Application Number

40587

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2008-03-19

Regulatory Status

Discontinued

2004
27 Jul
Discontinued Application: 40483

Drug Name

BETHANECHOL CHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2004-07-27

40483 / 1

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

40483

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2004-07-27

Regulatory Status

Discontinued

2004
27 Jul
Discontinued Application: 40485

Drug Name

BETHANECHOL CHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2004-07-27

40485 / 1

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

40485

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2004-07-27

Regulatory Status

Discontinued

2004
27 Jul
Discontinued Application: 40492

Drug Name

BETHANECHOL CHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2004-07-27

40492 / 1

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

40492

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2004-07-27

Regulatory Status

Discontinued

2004
27 Jul
Discontinued Application: 40509

Drug Name

BETHANECHOL CHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-07-27

40509 / 1

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

40509

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-07-27

Regulatory Status

Discontinued

2009
22 Apr
Discontinued Application: 40897

Drug Name

BETHANECHOL CHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2009-04-22

40897 / 1

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

40897

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2009-04-22

Regulatory Status

Discontinued

2009
22 Apr
Discontinued Application: 40897

Drug Name

BETHANECHOL CHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2009-04-22

40897 / 2

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

40897

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2009-04-22

Regulatory Status

Discontinued

2009
22 Apr
Discontinued Application: 40897

Drug Name

BETHANECHOL CHLORIDE

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

2009-04-22

40897 / 3

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

40897

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

2009-04-22

Regulatory Status

Discontinued

2009
22 Apr
Discontinued Application: 40897

Drug Name

BETHANECHOL CHLORIDE

Product Number

4

Dosage Form

-

Strength

50MG

Approval Date

2009-04-22

40897 / 4

Active Ingredient

BETHANECHOL CHLORIDE

Application Number

40897

Product Number

4

Dosage Form

-

Strength

50MG

Approval Date

2009-04-22

Regulatory Status

Discontinued

2010
06 Apr
Discontinued Application: 78866

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2010-04-06

78866 / 1

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

78866

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2010-04-06

Regulatory Status

Discontinued

2010
06 Apr
Discontinued Application: 78866

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2010-04-06

78866 / 2

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

78866

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2010-04-06

Regulatory Status

Discontinued

2010
06 Apr
Discontinued Application: 78866

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2010-04-06

78866 / 3

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

78866

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2010-04-06

Regulatory Status

Discontinued

2020
30 Nov
Discontinued Application: 200216

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2020-11-30

200216 / 1

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

200216

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2020-11-30

Regulatory Status

Discontinued

2014
18 Dec
Discontinued Application: 200695

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2014-12-18

200695 / 1

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

200695

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2014-12-18

Regulatory Status

Discontinued

2020
31 Dec
Discontinued Application: 203650

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2020-12-31

203650 / 1

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

203650

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2020-12-31

Regulatory Status

Discontinued

2001
23 Jul
Discontinued Application: 40390

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

2001-07-23

40390 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Application Number

40390

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

2001-07-23

Regulatory Status

Discontinued

2001
23 Jul
Discontinued Application: 40394

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

500MG;50MG;40MG

Approval Date

2001-07-23

40394 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Application Number

40394

Product Number

1

Dosage Form

-

Strength

500MG;50MG;40MG

Approval Date

2001-07-23

Regulatory Status

Discontinued

2003
21 Aug
Discontinued Application: 76528

Drug Name

BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG;30MG

Approval Date

2003-08-21

76528 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE

Application Number

76528

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG;30MG

Approval Date

2003-08-21

Regulatory Status

Discontinued

2009
30 Sep
Discontinued Application: 90077

Drug Name

CAFFEINE CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date

2009-09-30

90077 / 1

Active Ingredient

CAFFEINE CITRATE

Application Number

90077

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date

2009-09-30

Regulatory Status

Discontinued

2009
30 Sep
Discontinued Application: 90357

Drug Name

CAFFEINE CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date

2009-09-30

90357 / 1

Active Ingredient

CAFFEINE CITRATE

Application Number

90357

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date

2009-09-30

Regulatory Status

Discontinued

2019
21 Feb
Discontinued Application: 204556

Drug Name

CALCITRIOL

Product Number

1

Dosage Form

-

Strength

0.25MCG

Approval Date

2019-02-21

204556 / 1

Active Ingredient

CALCITRIOL

Application Number

204556

Product Number

1

Dosage Form

-

Strength

0.25MCG

Approval Date

2019-02-21

Regulatory Status

Discontinued

2019
21 Feb
Discontinued Application: 204556

Drug Name

CALCITRIOL

Product Number

2

Dosage Form

-

Strength

0.5MCG

Approval Date

2019-02-21

204556 / 2

Active Ingredient

CALCITRIOL

Application Number

204556

Product Number

2

Dosage Form

-

Strength

0.5MCG

Approval Date

2019-02-21

Regulatory Status

Discontinued

2019
21 Jun
Discontinued Application: 204668

Drug Name

CAPECITABINE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2019-06-21

204668 / 1

Active Ingredient

CAPECITABINE

Application Number

204668

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2019-06-21

Regulatory Status

Discontinued

2019
21 Jun
Discontinued Application: 204668

Drug Name

CAPECITABINE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2019-06-21

204668 / 2

Active Ingredient

CAPECITABINE

Application Number

204668

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2019-06-21

Regulatory Status

Discontinued

2007
23 Aug
Discontinued Application: 77828

Drug Name

CARBIDOPA AND LEVODOPA

Product Number

1

Dosage Form

-

Strength

25MG;100MG

Approval Date

2007-08-23

77828 / 1

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

77828

Product Number

1

Dosage Form

-

Strength

25MG;100MG

Approval Date

2007-08-23

Regulatory Status

Discontinued

2007
23 Aug
Discontinued Application: 77828

Drug Name

CARBIDOPA AND LEVODOPA

Product Number

2

Dosage Form

-

Strength

50MG;200MG

Approval Date

2007-08-23

77828 / 2

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

77828

Product Number

2

Dosage Form

-

Strength

50MG;200MG

Approval Date

2007-08-23

Regulatory Status

Discontinued

2012
10 May
Discontinued Application: 79085

Drug Name

CARBIDOPA, LEVODOPA AND ENTACAPONE

Product Number

1

Dosage Form

-

Strength

25MG;200MG;100MG

Approval Date

2012-05-10

79085 / 1

Active Ingredient

CARBIDOPA; ENTACAPONE; LEVODOPA

Application Number

79085

Product Number

1

Dosage Form

-

Strength

25MG;200MG;100MG

Approval Date

2012-05-10

Regulatory Status

Discontinued

2012
10 May
Discontinued Application: 79085

Drug Name

CARBIDOPA, LEVODOPA AND ENTACAPONE

Product Number

2

Dosage Form

-

Strength

37.5MG;200MG;150MG

Approval Date

2012-05-10

79085 / 2

Active Ingredient

CARBIDOPA; ENTACAPONE; LEVODOPA

Application Number

79085

Product Number

2

Dosage Form

-

Strength

37.5MG;200MG;150MG

Approval Date

2012-05-10

Regulatory Status

Discontinued

2022
30 Sep
Discontinued Application: 213932

Drug Name

CARIPRAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1.5MG BASE

Approval Date

2022-09-30

213932 / 1

Active Ingredient

CARIPRAZINE HYDROCHLORIDE

Application Number

213932

Product Number

1

Dosage Form

-

Strength

EQ 1.5MG BASE

Approval Date

2022-09-30

Regulatory Status

Discontinued

2022
30 Sep
Discontinued Application: 213932

Drug Name

CARIPRAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2022-09-30

213932 / 2

Active Ingredient

CARIPRAZINE HYDROCHLORIDE

Application Number

213932

Product Number

2

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2022-09-30

Regulatory Status

Discontinued

2022
30 Sep
Discontinued Application: 213932

Drug Name

CARIPRAZINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 4.5MG BASE

Approval Date

2022-09-30

213932 / 3

Active Ingredient

CARIPRAZINE HYDROCHLORIDE

Application Number

213932

Product Number

3

Dosage Form

-

Strength

EQ 4.5MG BASE

Approval Date

2022-09-30

Regulatory Status

Discontinued

2022
30 Sep
Discontinued Application: 213932

Drug Name

CARIPRAZINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 6MG BASE

Approval Date

2022-09-30

213932 / 4

Active Ingredient

CARIPRAZINE HYDROCHLORIDE

Application Number

213932

Product Number

4

Dosage Form

-

Strength

EQ 6MG BASE

Approval Date

2022-09-30

Regulatory Status

Discontinued

2001
21 Jun
Discontinued Application: 40421

Drug Name

CARISOPRODOL

Product Number

1

Dosage Form

-

Strength

350MG

Approval Date

2001-06-21

40421 / 1

Active Ingredient

CARISOPRODOL

Application Number

40421

Product Number

1

Dosage Form

-

Strength

350MG

Approval Date

2001-06-21

Regulatory Status

Discontinued

2007
27 Feb
Discontinued Application: 40755

Drug Name

CARISOPRODOL

Product Number

1

Dosage Form

-

Strength

350MG

Approval Date

2007-02-27

40755 / 1

Active Ingredient

CARISOPRODOL

Application Number

40755

Product Number

1

Dosage Form

-

Strength

350MG

Approval Date

2007-02-27

Regulatory Status

Discontinued

2007
05 Sep
Discontinued Application: 76989

Drug Name

CARVEDILOL

Product Number

1

Dosage Form

-

Strength

3.125MG

Approval Date

2007-09-05

76989 / 1

Active Ingredient

CARVEDILOL

Application Number

76989

Product Number

1

Dosage Form

-

Strength

3.125MG

Approval Date

2007-09-05

Regulatory Status

Discontinued

2007
05 Sep
Discontinued Application: 76989

Drug Name

CARVEDILOL

Product Number

2

Dosage Form

-

Strength

6.25MG

Approval Date

2007-09-05

76989 / 2

Active Ingredient

CARVEDILOL

Application Number

76989

Product Number

2

Dosage Form

-

Strength

6.25MG

Approval Date

2007-09-05

Regulatory Status

Discontinued

2007
05 Sep
Discontinued Application: 76989

Drug Name

CARVEDILOL

Product Number

3

Dosage Form

-

Strength

12.5MG

Approval Date

2007-09-05

76989 / 3

Active Ingredient

CARVEDILOL

Application Number

76989

Product Number

3

Dosage Form

-

Strength

12.5MG

Approval Date

2007-09-05

Regulatory Status

Discontinued

2007
05 Sep
Discontinued Application: 76989

Drug Name

CARVEDILOL

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2007-09-05

76989 / 4

Active Ingredient

CARVEDILOL

Application Number

76989

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2007-09-05

Regulatory Status

Discontinued

2007
05 Sep
Discontinued Application: 77346

Drug Name

CARVEDILOL

Product Number

1

Dosage Form

-

Strength

6.25MG

Approval Date

2007-09-05

77346 / 1

Active Ingredient

CARVEDILOL

Application Number

77346

Product Number

1

Dosage Form

-

Strength

6.25MG

Approval Date

2007-09-05

Regulatory Status

Discontinued

2007
05 Sep
Discontinued Application: 77346

Drug Name

CARVEDILOL

Product Number

2

Dosage Form

-

Strength

12.5MG

Approval Date

2007-09-05

77346 / 2

Active Ingredient

CARVEDILOL

Application Number

77346

Product Number

2

Dosage Form

-

Strength

12.5MG

Approval Date

2007-09-05

Regulatory Status

Discontinued

2007
05 Sep
Discontinued Application: 77346

Drug Name

CARVEDILOL

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

2007-09-05

77346 / 3

Active Ingredient

CARVEDILOL

Application Number

77346

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

2007-09-05

Regulatory Status

Discontinued

2007
05 Sep
Discontinued Application: 77346

Drug Name

CARVEDILOL

Product Number

4

Dosage Form

-

Strength

3.125MG

Approval Date

2007-09-05

77346 / 4

Active Ingredient

CARVEDILOL

Application Number

77346

Product Number

4

Dosage Form

-

Strength

3.125MG

Approval Date

2007-09-05

Regulatory Status

Discontinued

2003
26 Mar
Discontinued Application: 65115

Drug Name

CEFADROXIL

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

2003-03-26

65115 / 1

Active Ingredient

CEFADROXIL/CEFADROXIL HEMIHYDRATE

Application Number

65115

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

2003-03-26

Regulatory Status

Discontinued

2003
26 Mar
Discontinued Application: 65115

Drug Name

CEFADROXIL

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

2003-03-26

65115 / 2

Active Ingredient

CEFADROXIL/CEFADROXIL HEMIHYDRATE

Application Number

65115

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

2003-03-26

Regulatory Status

Discontinued

2003
26 Mar
Discontinued Application: 65115

Drug Name

CEFADROXIL

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE/5ML

Approval Date

2003-03-26

65115 / 3

Active Ingredient

CEFADROXIL/CEFADROXIL HEMIHYDRATE

Application Number

65115

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE/5ML

Approval Date

2003-03-26

Regulatory Status

Discontinued

2002
31 May
Discontinued Application: 65082

Drug Name

CEFPODOXIME PROXETIL

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/5ML

Approval Date

2002-05-31

65082 / 1

Active Ingredient

CEFPODOXIME PROXETIL

Application Number

65082

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/5ML

Approval Date

2002-05-31

Regulatory Status

Discontinued

2002
31 May
Discontinued Application: 65082

Drug Name

CEFPODOXIME PROXETIL

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/5ML

Approval Date

2002-05-31

65082 / 2

Active Ingredient

CEFPODOXIME PROXETIL

Application Number

65082

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/5ML

Approval Date

2002-05-31

Regulatory Status

Discontinued

2003
20 Aug
Discontinued Application: 65083

Drug Name

CEFPODOXIME PROXETIL

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2003-08-20

65083 / 1

Active Ingredient

CEFPODOXIME PROXETIL

Application Number

65083

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2003-08-20

Regulatory Status

Discontinued

2003
20 Aug
Discontinued Application: 65083

Drug Name

CEFPODOXIME PROXETIL

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2003-08-20

65083 / 2

Active Ingredient

CEFPODOXIME PROXETIL

Application Number

65083

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2003-08-20

Regulatory Status

Discontinued

2003
25 Apr
Discontinued Application: 65118

Drug Name

CEFUROXIME AXETIL

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE

Approval Date

2003-04-25

65118 / 1

Active Ingredient

CEFUROXIME AXETIL

Application Number

65118

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE

Approval Date

2003-04-25

Regulatory Status

Discontinued

2003
25 Apr
Discontinued Application: 65118

Drug Name

CEFUROXIME AXETIL

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2003-04-25

65118 / 2

Active Ingredient

CEFUROXIME AXETIL

Application Number

65118

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2003-04-25

Regulatory Status

Discontinued

2003
25 Apr
Discontinued Application: 65118

Drug Name

CEFUROXIME AXETIL

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2003-04-25

65118 / 3

Active Ingredient

CEFUROXIME AXETIL

Application Number

65118

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2003-04-25

Regulatory Status

Discontinued

2008
05 Feb
Discontinued Application: 65323

Drug Name

CEFUROXIME AXETIL

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

2008-02-05

65323 / 1

Active Ingredient

CEFUROXIME AXETIL

Application Number

65323

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

2008-02-05

Regulatory Status

Discontinued

2008
05 Feb
Discontinued Application: 65323

Drug Name

CEFUROXIME AXETIL

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

2008-02-05

65323 / 2

Active Ingredient

CEFUROXIME AXETIL

Application Number

65323

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

2008-02-05

Regulatory Status

Discontinued

1987
11 Jun
Discontinued Application: 62791

Drug Name

CEPHALEXIN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1987-06-11

62791 / 1

Active Ingredient

CEPHALEXIN

Application Number

62791

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1987-06-11

Regulatory Status

Discontinued

1987
11 Jun
Discontinued Application: 62791

Drug Name

CEPHALEXIN

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1987-06-11

62791 / 2

Active Ingredient

CEPHALEXIN

Application Number

62791

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1987-06-11

Regulatory Status

Discontinued

1999
16 Sep
Discontinued Application: 65007

Drug Name

CEPHALEXIN

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1999-09-16

65007 / 1

Active Ingredient

CEPHALEXIN

Application Number

65007

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1999-09-16

Regulatory Status

Discontinued

1999
16 Sep
Discontinued Application: 65007

Drug Name

CEPHALEXIN

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1999-09-16

65007 / 2

Active Ingredient

CEPHALEXIN

Application Number

65007

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

1999-09-16

Regulatory Status

Discontinued

2001
27 Jul
Discontinued Application: 65081

Drug Name

CEPHALEXIN

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

2001-07-27

65081 / 1

Active Ingredient

CEPHALEXIN

Application Number

65081

Product Number

1

Dosage Form

-

Strength

EQ 125MG BASE/5ML

Approval Date

2001-07-27

Regulatory Status

Discontinued

2001
27 Jul
Discontinued Application: 65081

Drug Name

CEPHALEXIN

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

2001-07-27

65081 / 2

Active Ingredient

CEPHALEXIN

Application Number

65081

Product Number

2

Dosage Form

-

Strength

EQ 250MG BASE/5ML

Approval Date

2001-07-27

Regulatory Status

Discontinued

2019
07 Jan
Discontinued Application: 202817

Drug Name

CERINTA

Product Number

1

Dosage Form

-

Strength

0.02MG;0.1MG

Approval Date

2019-01-07

202817 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

202817

Product Number

1

Dosage Form

-

Strength

0.02MG;0.1MG

Approval Date

2019-01-07

Regulatory Status

Discontinued

2007
27 Dec
Discontinued Application: 77499

Drug Name

CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-12-27

77499 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

77499

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-12-27

Regulatory Status

Discontinued

2007
27 Dec
Discontinued Application: 77499

Drug Name

CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-12-27

77499 / 2

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

77499

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-12-27

Regulatory Status

Discontinued

2008
11 Jan
Discontinued Application: 77631

Drug Name

CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2008-01-11

77631 / 3

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

77631

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2008-01-11

Regulatory Status

Discontinued

2008
11 Jan
Discontinued Application: 77631

Drug Name

CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

4

Dosage Form

-

Strength

5MG

Approval Date

2008-01-11

77631 / 4

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

77631

Product Number

4

Dosage Form

-

Strength

5MG

Approval Date

2008-01-11

Regulatory Status

Discontinued

2007
27 Dec
Discontinued Application: 77499

Drug Name

CETIRIZINE HYDROCHLORIDE HIVES

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2007-12-27

77499 / 3

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

77499

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2007-12-27

Regulatory Status

Discontinued

2007
27 Dec
Discontinued Application: 77499

Drug Name

CETIRIZINE HYDROCHLORIDE HIVES

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2007-12-27

77499 / 4

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

77499

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2007-12-27

Regulatory Status

Discontinued

2008
11 Jan
Discontinued Application: 77631

Drug Name

CETIRIZINE HYDROCHLORIDE HIVES RELIEF

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2008-01-11

77631 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

77631

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2008-01-11

Regulatory Status

Discontinued

2008
11 Jan
Discontinued Application: 77631

Drug Name

CETIRIZINE HYDROCHLORIDE HIVES RELIEF

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2008-01-11

77631 / 2

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

77631

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2008-01-11

Regulatory Status

Discontinued

2011
30 Aug
Discontinued Application: 90142

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-08-30

90142 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

90142

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-08-30

Regulatory Status

Discontinued

2011
30 Aug
Discontinued Application: 90142

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-08-30

90142 / 2

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

90142

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-08-30

Regulatory Status

Discontinued

2011
30 Aug
Discontinued Application: 90142

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2011-08-30

90142 / 3

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

90142

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2011-08-30

Regulatory Status

Discontinued

2011
30 Aug
Discontinued Application: 90142

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2011-08-30

90142 / 4

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

90142

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2011-08-30

Regulatory Status

Discontinued

2012
06 Feb
Discontinued Application: 91567

Drug Name

CHILDRENS FEXOFENADINE HYDROCHLORIDE ALLERGY

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2012-02-06

91567 / 2

Active Ingredient

FEXOFENADINE HYDROCHLORIDE

Application Number

91567

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2012-02-06

Regulatory Status

Discontinued

2012
06 Feb
Discontinued Application: 91567

Drug Name

CHILDRENS FEXOFENADINE HYDROCHLORIDE HIVES

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2012-02-06

91567 / 1

Active Ingredient

FEXOFENADINE HYDROCHLORIDE

Application Number

91567

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2012-02-06

Regulatory Status

Discontinued

2020
26 Oct
Discontinued Application: 214256

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2020-10-26

214256 / 1

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

214256

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2020-10-26

Regulatory Status

Discontinued

2020
26 Oct
Discontinued Application: 214256

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2020-10-26

214256 / 2

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

214256

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2020-10-26

Regulatory Status

Discontinued

2020
26 Oct
Discontinued Application: 214256

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2020-10-26

214256 / 3

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

214256

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2020-10-26

Regulatory Status

Discontinued

2020
26 Oct
Discontinued Application: 214256

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2020-10-26

214256 / 4

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

214256

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2020-10-26

Regulatory Status

Discontinued

2020
26 Oct
Discontinued Application: 214256

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

200MG

Approval Date

2020-10-26

214256 / 5

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

214256

Product Number

5

Dosage Form

-

Strength

200MG

Approval Date

2020-10-26

Regulatory Status

Discontinued

2018
11 Oct
Discontinued Application: 207008

Drug Name

CINACALCET HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2018-10-11

207008 / 1

Active Ingredient

CINACALCET HYDROCHLORIDE

Application Number

207008

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2018-10-11

Regulatory Status

Discontinued

2018
11 Oct
Discontinued Application: 207008

Drug Name

CINACALCET HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2018-10-11

207008 / 2

Active Ingredient

CINACALCET HYDROCHLORIDE

Application Number

207008

Product Number

2

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2018-10-11

Regulatory Status

Discontinued

2018
11 Oct
Discontinued Application: 207008

Drug Name

CINACALCET HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 90MG BASE

Approval Date

2018-10-11

207008 / 3

Active Ingredient

CINACALCET HYDROCHLORIDE

Application Number

207008

Product Number

3

Dosage Form

-

Strength

EQ 90MG BASE

Approval Date

2018-10-11

Regulatory Status

Discontinued

2004
09 Jun
Discontinued Application: 75747

Drug Name

CIPROFLOXACIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2004-06-09

75747 / 1

Active Ingredient

CIPROFLOXACIN HYDROCHLORIDE

Application Number

75747

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2004-06-09

Regulatory Status

Discontinued

2004
09 Jun
Discontinued Application: 75747

Drug Name

CIPROFLOXACIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2004-06-09

75747 / 2

Active Ingredient

CIPROFLOXACIN HYDROCHLORIDE

Application Number

75747

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2004-06-09

Regulatory Status

Discontinued

2004
09 Jun
Discontinued Application: 75747

Drug Name

CIPROFLOXACIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 750MG BASE

Approval Date

2004-06-09

75747 / 3

Active Ingredient

CIPROFLOXACIN HYDROCHLORIDE

Application Number

75747

Product Number

3

Dosage Form

-

Strength

EQ 750MG BASE

Approval Date

2004-06-09

Regulatory Status

Discontinued

2004
12 Nov
Discontinued Application: 77032

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2004-11-12

77032 / 1

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

77032

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2004-11-12

Regulatory Status

Discontinued

2004
12 Nov
Discontinued Application: 77032

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2004-11-12

77032 / 2

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

77032

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2004-11-12

Regulatory Status

Discontinued

2004
12 Nov
Discontinued Application: 77032

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2004-11-12

77032 / 3

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

77032

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2004-11-12

Regulatory Status

Discontinued

2004
24 Sep
Discontinued Application: 65174

Drug Name

CLARITHROMYCIN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2004-09-24

65174 / 1

Active Ingredient

CLARITHROMYCIN

Application Number

65174

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2004-09-24

Regulatory Status

Discontinued

2004
24 Sep
Discontinued Application: 65174

Drug Name

CLARITHROMYCIN

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2004-09-24

65174 / 2

Active Ingredient

CLARITHROMYCIN

Application Number

65174

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2004-09-24

Regulatory Status

Discontinued

2007
30 Aug
Discontinued Application: 65382

Drug Name

CLARITHROMYCIN

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

2007-08-30

65382 / 1

Active Ingredient

CLARITHROMYCIN

Application Number

65382

Product Number

1

Dosage Form

-

Strength

125MG/5ML

Approval Date

2007-08-30

Regulatory Status

Discontinued

2007
30 Aug
Discontinued Application: 65382

Drug Name

CLARITHROMYCIN

Product Number

2

Dosage Form

-

Strength

250MG/5ML

Approval Date

2007-08-30

65382 / 2

Active Ingredient

CLARITHROMYCIN

Application Number

65382

Product Number

2

Dosage Form

-

Strength

250MG/5ML

Approval Date

2007-08-30

Regulatory Status

Discontinued

2001
27 Apr
Discontinued Application: 75423

Drug Name

CLONAZEPAM

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2001-04-27

75423 / 1

Active Ingredient

CLONAZEPAM

Application Number

75423

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2001-04-27

Regulatory Status

Discontinued

2001
27 Apr
Discontinued Application: 75423

Drug Name

CLONAZEPAM

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2001-04-27

75423 / 2

Active Ingredient

CLONAZEPAM

Application Number

75423

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2001-04-27

Regulatory Status

Discontinued

2001
27 Apr
Discontinued Application: 75423

Drug Name

CLONAZEPAM

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2001-04-27

75423 / 3

Active Ingredient

CLONAZEPAM

Application Number

75423

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2001-04-27

Regulatory Status

Discontinued

2014
27 Aug
Discontinued Application: 78654

Drug Name

CLONAZEPAM

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2014-08-27

78654 / 1

Active Ingredient

CLONAZEPAM

Application Number

78654

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2014-08-27

Regulatory Status

Discontinued

2014
27 Aug
Discontinued Application: 78654

Drug Name

CLONAZEPAM

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2014-08-27

78654 / 2

Active Ingredient

CLONAZEPAM

Application Number

78654

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2014-08-27

Regulatory Status

Discontinued

2014
27 Aug
Discontinued Application: 78654

Drug Name

CLONAZEPAM

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

2014-08-27

78654 / 3

Active Ingredient

CLONAZEPAM

Application Number

78654

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

2014-08-27

Regulatory Status

Discontinued

2014
27 Aug
Discontinued Application: 78654

Drug Name

CLONAZEPAM

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

2014-08-27

78654 / 4

Active Ingredient

CLONAZEPAM

Application Number

78654

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

2014-08-27

Regulatory Status

Discontinued

2014
27 Aug
Discontinued Application: 78654

Drug Name

CLONAZEPAM

Product Number

5

Dosage Form

-

Strength

2MG

Approval Date

2014-08-27

78654 / 5

Active Ingredient

CLONAZEPAM

Application Number

78654

Product Number

5

Dosage Form

-

Strength

2MG

Approval Date

2014-08-27

Regulatory Status

Discontinued

2014
03 Jul
Discontinued Application: 90329

Drug Name

CLONIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2014-07-03

90329 / 1

Active Ingredient

CLONIDINE HYDROCHLORIDE

Application Number

90329

Product Number

1

Dosage Form

-

Strength

0.1MG

Approval Date

2014-07-03

Regulatory Status

Discontinued

2014
03 Jul
Discontinued Application: 90329

Drug Name

CLONIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

0.2MG

Approval Date

2014-07-03

90329 / 2

Active Ingredient

CLONIDINE HYDROCHLORIDE

Application Number

90329

Product Number

2

Dosage Form

-

Strength

0.2MG

Approval Date

2014-07-03

Regulatory Status

Discontinued

2014
03 Jul
Discontinued Application: 90329

Drug Name

CLONIDINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

0.3MG

Approval Date

2014-07-03

90329 / 3

Active Ingredient

CLONIDINE HYDROCHLORIDE

Application Number

90329

Product Number

3

Dosage Form

-

Strength

0.3MG

Approval Date

2014-07-03

Regulatory Status

Discontinued

2012
17 May
Discontinued Application: 90494

Drug Name

CLOPIDOGREL BISULFATE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2012-05-17

90494 / 1

Active Ingredient

CLOPIDOGREL BISULFATE

Application Number

90494

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2012-05-17

Regulatory Status

Discontinued

1987
14 Jul
Discontinued Application: 71777

Drug Name

CLORAZEPATE DIPOTASSIUM

Product Number

1

Dosage Form

-

Strength

3.75MG

Approval Date

1987-07-14

71777 / 1

Active Ingredient

CLORAZEPATE DIPOTASSIUM

Application Number

71777

Product Number

1

Dosage Form

-

Strength

3.75MG

Approval Date

1987-07-14

Regulatory Status

Discontinued

1987
14 Jul
Discontinued Application: 71778

Drug Name

CLORAZEPATE DIPOTASSIUM

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

1987-07-14

71778 / 1

Active Ingredient

CLORAZEPATE DIPOTASSIUM

Application Number

71778

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

1987-07-14

Regulatory Status

Discontinued

1987
14 Jul
Discontinued Application: 71779

Drug Name

CLORAZEPATE DIPOTASSIUM

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1987-07-14

71779 / 1

Active Ingredient

CLORAZEPATE DIPOTASSIUM

Application Number

71779

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1987-07-14

Regulatory Status

Discontinued

1987
26 Jun
Discontinued Application: 71780

Drug Name

CLORAZEPATE DIPOTASSIUM

Product Number

1

Dosage Form

-

Strength

3.75MG

Approval Date

1987-06-26

71780 / 1

Active Ingredient

CLORAZEPATE DIPOTASSIUM

Application Number

71780

Product Number

1

Dosage Form

-

Strength

3.75MG

Approval Date

1987-06-26

Regulatory Status

Discontinued

1987
26 Jun
Discontinued Application: 71781

Drug Name

CLORAZEPATE DIPOTASSIUM

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

1987-06-26

71781 / 1

Active Ingredient

CLORAZEPATE DIPOTASSIUM

Application Number

71781

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

1987-06-26

Regulatory Status

Discontinued

1987
26 Jun
Discontinued Application: 71782

Drug Name

CLORAZEPATE DIPOTASSIUM

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1987-06-26

71782 / 1

Active Ingredient

CLORAZEPATE DIPOTASSIUM

Application Number

71782

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1987-06-26

Regulatory Status

Discontinued

2004
29 Sep
Discontinued Application: 76911

Drug Name

CLORAZEPATE DIPOTASSIUM

Product Number

1

Dosage Form

-

Strength

3.75MG

Approval Date

2004-09-29

76911 / 1

Active Ingredient

CLORAZEPATE DIPOTASSIUM

Application Number

76911

Product Number

1

Dosage Form

-

Strength

3.75MG

Approval Date

2004-09-29

Regulatory Status

Discontinued

2004
29 Sep
Discontinued Application: 76911

Drug Name

CLORAZEPATE DIPOTASSIUM

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2004-09-29

76911 / 2

Active Ingredient

CLORAZEPATE DIPOTASSIUM

Application Number

76911

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2004-09-29

Regulatory Status

Discontinued

2004
29 Sep
Discontinued Application: 76911

Drug Name

CLORAZEPATE DIPOTASSIUM

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2004-09-29

76911 / 3

Active Ingredient

CLORAZEPATE DIPOTASSIUM

Application Number

76911

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2004-09-29

Regulatory Status

Discontinued

2002
15 Nov
Discontinued Application: 75713

Drug Name

CLOZAPINE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2002-11-15

75713 / 1

Active Ingredient

CLOZAPINE

Application Number

75713

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2002-11-15

Regulatory Status

Discontinued

2002
15 Nov
Discontinued Application: 75713

Drug Name

CLOZAPINE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2002-11-15

75713 / 2

Active Ingredient

CLOZAPINE

Application Number

75713

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2002-11-15

Regulatory Status

Discontinued

2005
19 Aug
Discontinued Application: 75713

Drug Name

CLOZAPINE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2005-08-19

75713 / 3

Active Ingredient

CLOZAPINE

Application Number

75713

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2005-08-19

Regulatory Status

Discontinued

2017
07 Nov
Discontinued Application: 75713

Drug Name

CLOZAPINE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2017-11-07

75713 / 4

Active Ingredient

CLOZAPINE

Application Number

75713

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2017-11-07

Regulatory Status

Discontinued

2008
12 May
Discontinued Application: 78722

Drug Name

CYCLOBENZAPRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2008-05-12

78722 / 1

Active Ingredient

CYCLOBENZAPRINE HYDROCHLORIDE

Application Number

78722

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2008-05-12

Regulatory Status

Discontinued

2008
12 May
Discontinued Application: 78722

Drug Name

CYCLOBENZAPRINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2008-05-12

78722 / 2

Active Ingredient

CYCLOBENZAPRINE HYDROCHLORIDE

Application Number

78722

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2008-05-12

Regulatory Status

Discontinued

2008
12 May
Discontinued Application: 78722

Drug Name

CYCLOBENZAPRINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2008-05-12

78722 / 3

Active Ingredient

CYCLOBENZAPRINE HYDROCHLORIDE

Application Number

78722

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2008-05-12

Regulatory Status

Discontinued

2019
21 May
Discontinued Application: 208292

Drug Name

DALFAMPRIDINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2019-05-21

208292 / 1

Active Ingredient

DALFAMPRIDINE

Application Number

208292

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2019-05-21

Regulatory Status

Discontinued

2014
28 Jan
Discontinued Application: 205582

Drug Name

DECITABINE

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2014-01-28

205582 / 1

Active Ingredient

DECITABINE

Application Number

205582

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2014-01-28

Regulatory Status

Discontinued

2020
02 Jan
Discontinued Application: 211641

Drug Name

DEFERASIROX

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2020-01-02

211641 / 1

Active Ingredient

DEFERASIROX

Application Number

211641

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2020-01-02

Regulatory Status

Discontinued

2020
02 Jan
Discontinued Application: 211641

Drug Name

DEFERASIROX

Product Number

2

Dosage Form

-

Strength

360MG

Approval Date

2020-01-02

211641 / 2

Active Ingredient

DEFERASIROX

Application Number

211641

Product Number

2

Dosage Form

-

Strength

360MG

Approval Date

2020-01-02

Regulatory Status

Discontinued

2020
15 Jun
Discontinued Application: 211641

Drug Name

DEFERASIROX

Product Number

3

Dosage Form

-

Strength

180MG

Approval Date

2020-06-15

211641 / 3

Active Ingredient

DEFERASIROX

Application Number

211641

Product Number

3

Dosage Form

-

Strength

180MG

Approval Date

2020-06-15

Regulatory Status

Discontinued

2010
16 Nov
Discontinued Application: 78359

Drug Name

DESLORATADINE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2010-11-16

78359 / 1

Active Ingredient

DESLORATADINE

Application Number

78359

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2010-11-16

Regulatory Status

Discontinued

2012
12 Apr
Discontinued Application: 77212

Drug Name

DESMOPRESSIN ACETATE

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

2012-04-12

77212 / 1

Active Ingredient

DESMOPRESSIN ACETATE

Application Number

77212

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

2012-04-12

Regulatory Status

Discontinued

2013
25 Jan
Discontinued Application: 91280

Drug Name

DESMOPRESSIN ACETATE

Product Number

1

Dosage Form

-

Strength

0.004MG/ML

Approval Date

2013-01-25

91280 / 1

Active Ingredient

DESMOPRESSIN ACETATE

Application Number

91280

Product Number

1

Dosage Form

-

Strength

0.004MG/ML

Approval Date

2013-01-25

Regulatory Status

Discontinued

2013
23 Dec
Discontinued Application: 78271

Drug Name

DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)

Product Number

1

Dosage Form

-

Strength

0.01MG/SPRAY

Approval Date

2013-12-23

78271 / 1

Active Ingredient

DESMOPRESSIN ACETATE

Application Number

78271

Product Number

1

Dosage Form

-

Strength

0.01MG/SPRAY

Approval Date

2013-12-23

Regulatory Status

Discontinued

2014
28 Jan
Discontinued Application: 205583

Drug Name

DESVENLAFAXINE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2014-01-28

205583 / 1

Active Ingredient

DESVENLAFAXINE FUMARATE

Application Number

205583

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2014-01-28

Regulatory Status

Discontinued

2014
28 Jan
Discontinued Application: 205583

Drug Name

DESVENLAFAXINE

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2014-01-28

205583 / 2

Active Ingredient

DESVENLAFAXINE FUMARATE

Application Number

205583

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2014-01-28

Regulatory Status

Discontinued

2021
05 Nov
Discontinued Application: 206734

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2021-11-05

206734 / 1

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

206734

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2021-11-05

Regulatory Status

Discontinued

2021
05 Nov
Discontinued Application: 206734

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2021-11-05

206734 / 2

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

206734

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2021-11-05

Regulatory Status

Discontinued

2021
05 Nov
Discontinued Application: 206734

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2021-11-05

206734 / 3

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

206734

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2021-11-05

Regulatory Status

Discontinued

2021
05 Nov
Discontinued Application: 206734

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2021-11-05

206734 / 4

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

206734

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2021-11-05

Regulatory Status

Discontinued

2021
05 Nov
Discontinued Application: 206734

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

25MG

Approval Date

2021-11-05

206734 / 5

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

206734

Product Number

5

Dosage Form

-

Strength

25MG

Approval Date

2021-11-05

Regulatory Status

Discontinued

2021
05 Nov
Discontinued Application: 206734

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2021-11-05

206734 / 6

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

206734

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2021-11-05

Regulatory Status

Discontinued

2021
05 Nov
Discontinued Application: 206734

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

7

Dosage Form

-

Strength

35MG

Approval Date

2021-11-05

206734 / 7

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

206734

Product Number

7

Dosage Form

-

Strength

35MG

Approval Date

2021-11-05

Regulatory Status

Discontinued

2021
05 Nov
Discontinued Application: 206734

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

8

Dosage Form

-

Strength

40MG

Approval Date

2021-11-05

206734 / 8

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

206734

Product Number

8

Dosage Form

-

Strength

40MG

Approval Date

2021-11-05

Regulatory Status

Discontinued

2004
25 Aug
Discontinued Application: 76814

Drug Name

DEXTROAMPHETAMINE SULFATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2004-08-25

76814 / 1

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

76814

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2004-08-25

Regulatory Status

Discontinued

2004
25 Aug
Discontinued Application: 76814

Drug Name

DEXTROAMPHETAMINE SULFATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2004-08-25

76814 / 2

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

76814

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2004-08-25

Regulatory Status

Discontinued

2004
25 Aug
Discontinued Application: 76814

Drug Name

DEXTROAMPHETAMINE SULFATE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2004-08-25

76814 / 3

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

76814

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2004-08-25

Regulatory Status

Discontinued

2003
31 Jan
Discontinued Application: 76363

Drug Name

DIGOXIN

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2003-01-31

76363 / 1

Active Ingredient

DIGOXIN

Application Number

76363

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2003-01-31

Regulatory Status

Discontinued

2003
31 Jan
Discontinued Application: 76363

Drug Name

DIGOXIN

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2003-01-31

76363 / 2

Active Ingredient

DIGOXIN

Application Number

76363

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2003-01-31

Regulatory Status

Discontinued

2010
15 Nov
Discontinued Application: 90421

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2010-11-15

90421 / 1

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

90421

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2010-11-15

Regulatory Status

Discontinued

2010
15 Nov
Discontinued Application: 90421

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2010-11-15

90421 / 2

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

90421

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2010-11-15

Regulatory Status

Discontinued

2010
15 Nov
Discontinued Application: 90421

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

240MG

Approval Date

2010-11-15

90421 / 3

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

90421

Product Number

3

Dosage Form

-

Strength

240MG

Approval Date

2010-11-15

Regulatory Status

Discontinued

2010
15 Nov
Discontinued Application: 90421

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

300MG

Approval Date

2010-11-15

90421 / 4

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

90421

Product Number

4

Dosage Form

-

Strength

300MG

Approval Date

2010-11-15

Regulatory Status

Discontinued

2010
15 Nov
Discontinued Application: 90421

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

360MG

Approval Date

2010-11-15

90421 / 5

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

90421

Product Number

5

Dosage Form

-

Strength

360MG

Approval Date

2010-11-15

Regulatory Status

Discontinued

2011
28 Oct
Discontinued Application: 90492

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2011-10-28

90492 / 1

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

90492

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2011-10-28

Regulatory Status

Discontinued

2011
28 Oct
Discontinued Application: 90492

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2011-10-28

90492 / 2

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

90492

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2011-10-28

Regulatory Status

Discontinued

2011
28 Oct
Discontinued Application: 90492

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

240MG

Approval Date

2011-10-28

90492 / 3

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

90492

Product Number

3

Dosage Form

-

Strength

240MG

Approval Date

2011-10-28

Regulatory Status

Discontinued

2011
28 Oct
Discontinued Application: 90492

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

300MG

Approval Date

2011-10-28

90492 / 4

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

90492

Product Number

4

Dosage Form

-

Strength

300MG

Approval Date

2011-10-28

Regulatory Status

Discontinued

2011
28 Oct
Discontinued Application: 90492

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

360MG

Approval Date

2011-10-28

90492 / 5

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

90492

Product Number

5

Dosage Form

-

Strength

360MG

Approval Date

2011-10-28

Regulatory Status

Discontinued

2017
08 Jun
Discontinued Application: 203023

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2017-06-08

203023 / 1

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

203023

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2017-06-08

Regulatory Status

Discontinued

2017
08 Jun
Discontinued Application: 203023

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2017-06-08

203023 / 2

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

203023

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2017-06-08

Regulatory Status

Discontinued

2017
08 Jun
Discontinued Application: 203023

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

240MG

Approval Date

2017-06-08

203023 / 3

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

203023

Product Number

3

Dosage Form

-

Strength

240MG

Approval Date

2017-06-08

Regulatory Status

Discontinued

2017
08 Jun
Discontinued Application: 203023

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

300MG

Approval Date

2017-06-08

203023 / 4

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

203023

Product Number

4

Dosage Form

-

Strength

300MG

Approval Date

2017-06-08

Regulatory Status

Discontinued

2000
27 Nov
Discontinued Application: 40395

Drug Name

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Product Number

1

Dosage Form

-

Strength

0.025MG;2.5MG

Approval Date

2000-11-27

40395 / 1

Active Ingredient

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

Application Number

40395

Product Number

1

Dosage Form

-

Strength

0.025MG;2.5MG

Approval Date

2000-11-27

Regulatory Status

Discontinued

2011
03 May
Discontinued Application: 22534

Drug Name

DOCEFREZ

Product Number

1

Dosage Form

-

Strength

20MG/VIAL

Approval Date

2011-05-03

22534 / 1

Active Ingredient

DOCETAXEL

Application Number

22534

Product Number

1

Dosage Form

-

Strength

20MG/VIAL

Approval Date

2011-05-03

Regulatory Status

Discontinued

2011
03 May
Discontinued Application: 22534

Drug Name

DOCEFREZ

Product Number

2

Dosage Form

-

Strength

80MG/VIAL

Approval Date

2011-05-03

22534 / 2

Active Ingredient

DOCETAXEL

Application Number

22534

Product Number

2

Dosage Form

-

Strength

80MG/VIAL

Approval Date

2011-05-03

Regulatory Status

Discontinued

2019
08 Jan
Discontinued Application: 22534

Drug Name

DOCETAXEL

Product Number

3

Dosage Form

-

Strength

20MG/ML (20MG/ML)

Approval Date

2019-01-08

22534 / 3

Active Ingredient

DOCETAXEL

Application Number

22534

Product Number

3

Dosage Form

-

Strength

20MG/ML (20MG/ML)

Approval Date

2019-01-08

Regulatory Status

Discontinued

2019
08 Jan
Discontinued Application: 22534

Drug Name

DOCETAXEL

Product Number

4

Dosage Form

-

Strength

80MG/4ML (20MG/ML)

Approval Date

2019-01-08

22534 / 4

Active Ingredient

DOCETAXEL

Application Number

22534

Product Number

4

Dosage Form

-

Strength

80MG/4ML (20MG/ML)

Approval Date

2019-01-08

Regulatory Status

Discontinued

2019
08 Jan
Discontinued Application: 22534

Drug Name

DOCETAXEL

Product Number

5

Dosage Form

-

Strength

160MG/8ML (20MG/ML)

Approval Date

2019-01-08

22534 / 5

Active Ingredient

DOCETAXEL

Application Number

22534

Product Number

5

Dosage Form

-

Strength

160MG/8ML (20MG/ML)

Approval Date

2019-01-08

Regulatory Status

Discontinued

2010
26 Nov
Discontinued Application: 76786

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2010-11-26

76786 / 1

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

76786

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2010-11-26

Regulatory Status

Discontinued

2010
26 Nov
Discontinued Application: 76786

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2010-11-26

76786 / 2

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

76786

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2010-11-26

Regulatory Status

Discontinued

2011
31 May
Discontinued Application: 90493

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-05-31

90493 / 1

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

90493

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-05-31

Regulatory Status

Discontinued

2011
31 May
Discontinued Application: 90493

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-05-31

90493 / 2

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

90493

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-05-31

Regulatory Status

Discontinued

2015
05 Jun
Discontinued Application: 204293

Drug Name

DONEPEZIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

23MG

Approval Date

2015-06-05

204293 / 1

Active Ingredient

DONEPEZIL HYDROCHLORIDE

Application Number

204293

Product Number

1

Dosage Form

-

Strength

23MG

Approval Date

2015-06-05

Regulatory Status

Discontinued

2019
14 Nov
Discontinued Application: 203875

Drug Name

DOXERCALCIFEROL

Product Number

1

Dosage Form

-

Strength

2MCG/ML (2MCG/ML)

Approval Date

2019-11-14

203875 / 1

Active Ingredient

DOXERCALCIFEROL

Application Number

203875

Product Number

1

Dosage Form

-

Strength

2MCG/ML (2MCG/ML)

Approval Date

2019-11-14

Regulatory Status

Discontinued

2019
14 Nov
Discontinued Application: 203875

Drug Name

DOXERCALCIFEROL

Product Number

2

Dosage Form

-

Strength

4MCG/2ML (2MCG/ML)

Approval Date

2019-11-14

203875 / 2

Active Ingredient

DOXERCALCIFEROL

Application Number

203875

Product Number

2

Dosage Form

-

Strength

4MCG/2ML (2MCG/ML)

Approval Date

2019-11-14

Regulatory Status

Discontinued

2013
11 Dec
Discontinued Application: 90745

Drug Name

DULOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2013-12-11

90745 / 1

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

90745

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2013-12-11

Regulatory Status

Discontinued

2013
11 Dec
Discontinued Application: 90745

Drug Name

DULOXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2013-12-11

90745 / 2

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

90745

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2013-12-11

Regulatory Status

Discontinued

2013
11 Dec
Discontinued Application: 90745

Drug Name

DULOXETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2013-12-11

90745 / 3

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

90745

Product Number

3

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2013-12-11

Regulatory Status

Discontinued

2000
22 Aug
Discontinued Application: 75556

Drug Name

ENALAPRIL MALEATE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2000-08-22

75556 / 1

Active Ingredient

ENALAPRIL MALEATE

Application Number

75556

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2000-08-22

Regulatory Status

Discontinued

2000
22 Aug
Discontinued Application: 75556

Drug Name

ENALAPRIL MALEATE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2000-08-22

75556 / 2

Active Ingredient

ENALAPRIL MALEATE

Application Number

75556

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2000-08-22

Regulatory Status

Discontinued

2000
22 Aug
Discontinued Application: 75556

Drug Name

ENALAPRIL MALEATE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2000-08-22

75556 / 3

Active Ingredient

ENALAPRIL MALEATE

Application Number

75556

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2000-08-22

Regulatory Status

Discontinued

2000
22 Aug
Discontinued Application: 75556

Drug Name

ENALAPRIL MALEATE

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2000-08-22

75556 / 4

Active Ingredient

ENALAPRIL MALEATE

Application Number

75556

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2000-08-22

Regulatory Status

Discontinued

2011
31 Oct
Discontinued Application: 91626

Drug Name

EPINASTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2011-10-31

91626 / 1

Active Ingredient

EPINASTINE HYDROCHLORIDE

Application Number

91626

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2011-10-31

Regulatory Status

Discontinued

2009
29 Dec
Discontinued Application: 40865

Drug Name

ERGOCALCIFEROL

Product Number

1

Dosage Form

-

Strength

50,000 IU

Approval Date

2009-12-29

40865 / 1

Active Ingredient

ERGOCALCIFEROL

Application Number

40865

Product Number

1

Dosage Form

-

Strength

50,000 IU

Approval Date

2009-12-29

Regulatory Status

Discontinued

2019
05 Nov
Discontinued Application: 210300

Drug Name

ERLOTINIB HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2019-11-05

210300 / 1

Active Ingredient

ERLOTINIB HYDROCHLORIDE

Application Number

210300

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2019-11-05

Regulatory Status

Discontinued

2019
05 Nov
Discontinued Application: 210300

Drug Name

ERLOTINIB HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2019-11-05

210300 / 2

Active Ingredient

ERLOTINIB HYDROCHLORIDE

Application Number

210300

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2019-11-05

Regulatory Status

Discontinued

2019
05 Nov
Discontinued Application: 210300

Drug Name

ERLOTINIB HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2019-11-05

210300 / 3

Active Ingredient

ERLOTINIB HYDROCHLORIDE

Application Number

210300

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2019-11-05

Regulatory Status

Discontinued

2023
02 May
Discontinued Application: 209145

Drug Name

ERTAPENEM SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2023-05-02

209145 / 1

Active Ingredient

ERTAPENEM SODIUM

Application Number

209145

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2023-05-02

Regulatory Status

Discontinued

2013
18 Mar
Discontinued Application: 200882

Drug Name

ESOMEPRAZOLE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/VIAL

Approval Date

2013-03-18

200882 / 1

Active Ingredient

ESOMEPRAZOLE SODIUM

Application Number

200882

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/VIAL

Approval Date

2013-03-18

Regulatory Status

Discontinued

2013
18 Mar
Discontinued Application: 200882

Drug Name

ESOMEPRAZOLE SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2013-03-18

200882 / 2

Active Ingredient

ESOMEPRAZOLE SODIUM

Application Number

200882

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2013-03-18

Regulatory Status

Discontinued

2006
11 Dec
Discontinued Application: 40621

Drug Name

EXTENDED PHENYTOIN SODIUM

Product Number

1

Dosage Form

-

Strength

100MG EXTENDED

Approval Date

2006-12-11

40621 / 1

Active Ingredient

PHENYTOIN SODIUM

Application Number

40621

Product Number

1

Dosage Form

-

Strength

100MG EXTENDED

Approval Date

2006-12-11

Regulatory Status

Discontinued

2008
30 Jun
Discontinued Application: 40731

Drug Name

EXTENDED PHENYTOIN SODIUM

Product Number

1

Dosage Form

-

Strength

200MG EXTENDED

Approval Date

2008-06-30

40731 / 1

Active Ingredient

PHENYTOIN SODIUM

Application Number

40731

Product Number

1

Dosage Form

-

Strength

200MG EXTENDED

Approval Date

2008-06-30

Regulatory Status

Discontinued

2008
30 Jun
Discontinued Application: 40731

Drug Name

EXTENDED PHENYTOIN SODIUM

Product Number

2

Dosage Form

-

Strength

300MG EXTENDED

Approval Date

2008-06-30

40731 / 2

Active Ingredient

PHENYTOIN SODIUM

Application Number

40731

Product Number

2

Dosage Form

-

Strength

300MG EXTENDED

Approval Date

2008-06-30

Regulatory Status

Discontinued

2018
18 Dec
Discontinued Application: 208647

Drug Name

EZALLOR SPRINKLE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2018-12-18

208647 / 1

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

208647

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2018-12-18

Regulatory Status

Discontinued

2018
18 Dec
Discontinued Application: 208647

Drug Name

EZALLOR SPRINKLE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2018-12-18

208647 / 2

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

208647

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2018-12-18

Regulatory Status

Discontinued

2018
18 Dec
Discontinued Application: 208647

Drug Name

EZALLOR SPRINKLE

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2018-12-18

208647 / 3

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

208647

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2018-12-18

Regulatory Status

Discontinued

2018
18 Dec
Discontinued Application: 208647

Drug Name

EZALLOR SPRINKLE

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2018-12-18

208647 / 4

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

208647

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2018-12-18

Regulatory Status

Discontinued

2009
17 Nov
Discontinued Application: 90283

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2009-11-17

90283 / 1

Active Ingredient

FAMOTIDINE

Application Number

90283

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2009-11-17

Regulatory Status

Discontinued

2009
17 Nov
Discontinued Application: 90283

Drug Name

FAMOTIDINE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2009-11-17

90283 / 2

Active Ingredient

FAMOTIDINE

Application Number

90283

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2009-11-17

Regulatory Status

Discontinued

2005
31 Oct
Discontinued Application: 76635

Drug Name

FENOFIBRATE

Product Number

1

Dosage Form

-

Strength

54MG

Approval Date

2005-10-31

76635 / 1

Active Ingredient

FENOFIBRATE

Application Number

76635

Product Number

1

Dosage Form

-

Strength

54MG

Approval Date

2005-10-31

Regulatory Status

Discontinued

2005
31 Oct
Discontinued Application: 76635

Drug Name

FENOFIBRATE

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2005-10-31

76635 / 3

Active Ingredient

FENOFIBRATE

Application Number

76635

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2005-10-31

Regulatory Status

Discontinued

2017
07 Sep
Discontinued Application: 200884

Drug Name

FENOFIBRATE

Product Number

1

Dosage Form

-

Strength

48MG

Approval Date

2017-09-07

200884 / 1

Active Ingredient

FENOFIBRATE

Application Number

200884

Product Number

1

Dosage Form

-

Strength

48MG

Approval Date

2017-09-07

Regulatory Status

Discontinued

2017
07 Sep
Discontinued Application: 200884

Drug Name

FENOFIBRATE

Product Number

2

Dosage Form

-

Strength

145MG

Approval Date

2017-09-07

200884 / 2

Active Ingredient

FENOFIBRATE

Application Number

200884

Product Number

2

Dosage Form

-

Strength

145MG

Approval Date

2017-09-07

Regulatory Status

Discontinued

2014
31 Oct
Discontinued Application: 201748

Drug Name

FENOFIBRATE (MICRONIZED)

Product Number

1

Dosage Form

-

Strength

43MG

Approval Date

2014-10-31

201748 / 1

Active Ingredient

FENOFIBRATE

Application Number

201748

Product Number

1

Dosage Form

-

Strength

43MG

Approval Date

2014-10-31

Regulatory Status

Discontinued

2014
31 Oct
Discontinued Application: 201748

Drug Name

FENOFIBRATE (MICRONIZED)

Product Number

2

Dosage Form

-

Strength

130MG

Approval Date

2014-10-31

201748 / 2

Active Ingredient

FENOFIBRATE

Application Number

201748

Product Number

2

Dosage Form

-

Strength

130MG

Approval Date

2014-10-31

Regulatory Status

Discontinued

2012
06 Feb
Discontinued Application: 91567

Drug Name

FEXOFENADINE HYDROCHLORIDE ALLERGY

Product Number

4

Dosage Form

-

Strength

60MG

Approval Date

2012-02-06

91567 / 4

Active Ingredient

FEXOFENADINE HYDROCHLORIDE

Application Number

91567

Product Number

4

Dosage Form

-

Strength

60MG

Approval Date

2012-02-06

Regulatory Status

Discontinued

2012
06 Feb
Discontinued Application: 91567

Drug Name

FEXOFENADINE HYDROCHLORIDE HIVES

Product Number

3

Dosage Form

-

Strength

60MG

Approval Date

2012-02-06

91567 / 3

Active Ingredient

FEXOFENADINE HYDROCHLORIDE

Application Number

91567

Product Number

3

Dosage Form

-

Strength

60MG

Approval Date

2012-02-06

Regulatory Status

Discontinued

2019
04 Dec
Discontinued Application: 208014

Drug Name

FINGOLIMOD HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2019-12-04

208014 / 1

Active Ingredient

FINGOLIMOD HYDROCHLORIDE

Application Number

208014

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2019-12-04

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 76332

Drug Name

FLUCONAZOLE

Product Number

1

Dosage Form

-

Strength

50MG/5ML

Approval Date

2004-07-29

76332 / 1

Active Ingredient

FLUCONAZOLE

Application Number

76332

Product Number

1

Dosage Form

-

Strength

50MG/5ML

Approval Date

2004-07-29

Regulatory Status

Discontinued

2004
29 Jul
Discontinued Application: 76332

Drug Name

FLUCONAZOLE

Product Number

2

Dosage Form

-

Strength

200MG/5ML

Approval Date

2004-07-29

76332 / 2

Active Ingredient

FLUCONAZOLE

Application Number

76332

Product Number

2

Dosage Form

-

Strength

200MG/5ML

Approval Date

2004-07-29

Regulatory Status

Discontinued

1993
17 Sep
Discontinued Application: 19649

Drug Name

FLUMADINE

Product Number

1

Dosage Form

-

Strength

100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-09-17

19649 / 1

Active Ingredient

RIMANTADINE HYDROCHLORIDE

Application Number

19649

Product Number

1

Dosage Form

-

Strength

100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-09-17

Regulatory Status

Discontinued

2004
13 Dec
Discontinued Application: 76990

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2004-12-13

76990 / 1

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

76990

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2004-12-13

Regulatory Status

Discontinued

2001
27 Apr
Discontinued Application: 75058

Drug Name

FLURBIPROFEN

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2001-04-27

75058 / 1

Active Ingredient

FLURBIPROFEN

Application Number

75058

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2001-04-27

Regulatory Status

Discontinued

2001
27 Apr
Discontinued Application: 75058

Drug Name

FLURBIPROFEN

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2001-04-27

75058 / 2

Active Ingredient

FLURBIPROFEN

Application Number

75058

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2001-04-27

Regulatory Status

Discontinued

2004
17 Dec
Discontinued Application: 76739

Drug Name

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

10MG;12.5MG

Approval Date

2004-12-17

76739 / 1

Active Ingredient

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

Application Number

76739

Product Number

1

Dosage Form

-

Strength

10MG;12.5MG

Approval Date

2004-12-17

Regulatory Status

Discontinued

2004
17 Dec
Discontinued Application: 76739

Drug Name

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

20MG;12.5MG

Approval Date

2004-12-17

76739 / 2

Active Ingredient

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

Application Number

76739

Product Number

2

Dosage Form

-

Strength

20MG;12.5MG

Approval Date

2004-12-17

Regulatory Status

Discontinued

1983
29 Nov
Discontinued Application: 18790

Drug Name

FUROSEMIDE

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1983-11-29

18790 / 1

Active Ingredient

FUROSEMIDE

Application Number

18790

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1983-11-29

Regulatory Status

Discontinued

2014
01 Apr
Discontinued Application: 91258

Drug Name

FUROSEMIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2014-04-01

91258 / 1

Active Ingredient

FUROSEMIDE

Application Number

91258

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2014-04-01

Regulatory Status

Discontinued

2014
01 Apr
Discontinued Application: 91258

Drug Name

FUROSEMIDE

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2014-04-01

91258 / 2

Active Ingredient

FUROSEMIDE

Application Number

91258

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2014-04-01

Regulatory Status

Discontinued

2014
01 Apr
Discontinued Application: 91258

Drug Name

FUROSEMIDE

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

2014-04-01

91258 / 3

Active Ingredient

FUROSEMIDE

Application Number

91258

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

2014-04-01

Regulatory Status

Discontinued

2005
07 Oct
Discontinued Application: 76606

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2005-10-07

76606 / 1

Active Ingredient

GABAPENTIN

Application Number

76606

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2005-10-07

Regulatory Status

Discontinued

2005
07 Oct
Discontinued Application: 76606

Drug Name

GABAPENTIN

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2005-10-07

76606 / 2

Active Ingredient

GABAPENTIN

Application Number

76606

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2005-10-07

Regulatory Status

Discontinued

2005
07 Oct
Discontinued Application: 76606

Drug Name

GABAPENTIN

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2005-10-07

76606 / 3

Active Ingredient

GABAPENTIN

Application Number

76606

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2005-10-07

Regulatory Status

Discontinued

2006
24 Aug
Discontinued Application: 77242

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2006-08-24

77242 / 1

Active Ingredient

GABAPENTIN

Application Number

77242

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2006-08-24

Regulatory Status

Discontinued

2006
24 Aug
Discontinued Application: 77242

Drug Name

GABAPENTIN

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2006-08-24

77242 / 2

Active Ingredient

GABAPENTIN

Application Number

77242

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2006-08-24

Regulatory Status

Discontinued

2006
24 Aug
Discontinued Application: 77242

Drug Name

GABAPENTIN

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2006-08-24

77242 / 3

Active Ingredient

GABAPENTIN

Application Number

77242

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2006-08-24

Regulatory Status

Discontinued

2006
24 Aug
Discontinued Application: 77525

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2006-08-24

77525 / 1

Active Ingredient

GABAPENTIN

Application Number

77525

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2006-08-24

Regulatory Status

Discontinued

2006
24 Aug
Discontinued Application: 77525

Drug Name

GABAPENTIN

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

2006-08-24

77525 / 2

Active Ingredient

GABAPENTIN

Application Number

77525

Product Number

2

Dosage Form

-

Strength

800MG

Approval Date

2006-08-24

Regulatory Status

Discontinued

2008
29 Dec
Discontinued Application: 79239

Drug Name

GEMFIBROZIL

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2008-12-29

79239 / 1

Active Ingredient

GEMFIBROZIL

Application Number

79239

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2008-12-29

Regulatory Status

Discontinued

2006
11 Jul
Discontinued Application: 77820

Drug Name

GLIPIZIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2006-07-11

77820 / 1

Active Ingredient

GLIPIZIDE

Application Number

77820

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2006-07-11

Regulatory Status

Discontinued

2006
11 Jul
Discontinued Application: 77820

Drug Name

GLIPIZIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2006-07-11

77820 / 2

Active Ingredient

GLIPIZIDE

Application Number

77820

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2006-07-11

Regulatory Status

Discontinued

2008
11 Jan
Discontinued Application: 77620

Drug Name

GLIPIZIDE AND METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5MG;250MG

Approval Date

2008-01-11

77620 / 1

Active Ingredient

GLIPIZIDE; METFORMIN HYDROCHLORIDE

Application Number

77620

Product Number

1

Dosage Form

-

Strength

2.5MG;250MG

Approval Date

2008-01-11

Regulatory Status

Discontinued

2008
11 Jan
Discontinued Application: 77620

Drug Name

GLIPIZIDE AND METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

2.5MG;500MG

Approval Date

2008-01-11

77620 / 2

Active Ingredient

GLIPIZIDE; METFORMIN HYDROCHLORIDE

Application Number

77620

Product Number

2

Dosage Form

-

Strength

2.5MG;500MG

Approval Date

2008-01-11

Regulatory Status

Discontinued

2008
11 Jan
Discontinued Application: 77620

Drug Name

GLIPIZIDE AND METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

5MG;500MG

Approval Date

2008-01-11

77620 / 3

Active Ingredient

GLIPIZIDE; METFORMIN HYDROCHLORIDE

Application Number

77620

Product Number

3

Dosage Form

-

Strength

5MG;500MG

Approval Date

2008-01-11

Regulatory Status

Discontinued

2017
16 Nov
Discontinued Application: 205689

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2017-11-16

205689 / 1

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

205689

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2017-11-16

Regulatory Status

Discontinued

2017
16 Nov
Discontinued Application: 205689

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2017-11-16

205689 / 2

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

205689

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2017-11-16

Regulatory Status

Discontinued

2017
16 Nov
Discontinued Application: 205689

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2017-11-16

205689 / 3

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

205689

Product Number

3

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2017-11-16

Regulatory Status

Discontinued

2017
16 Nov
Discontinued Application: 205689

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2017-11-16

205689 / 4

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

205689

Product Number

4

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2017-11-16

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17824

Drug Name

HALOG

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

17824 / 1

Active Ingredient

HALCINONIDE

Application Number

17824

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18234

Drug Name

HALOG-E

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

18234 / 1

Active Ingredient

HALCINONIDE

Application Number

18234

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1992
19 Jun
Discontinued Application: 81274

Drug Name

HEMSOL-HC

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1992-06-19

81274 / 1

Active Ingredient

HYDROCORTISONE ACETATE

Application Number

81274

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1992-06-19

Regulatory Status

Discontinued

1982
16 Mar
Discontinued Application: 18467

Drug Name

HEPATOLITE

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

1982-03-16

18467 / 1

Active Ingredient

TECHNETIUM TC-99M DISOFENIN KIT

Application Number

18467

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

1982-03-16

Regulatory Status

Discontinued

2007
27 Mar
Discontinued Application: 40810

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2007-03-27

40810 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

40810

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2007-03-27

Regulatory Status

Discontinued

2007
27 Mar
Discontinued Application: 40810

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2007-03-27

40810 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

40810

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2007-03-27

Regulatory Status

Discontinued

2008
30 May
Discontinued Application: 40857

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2008-05-30

40857 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

40857

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2008-05-30

Regulatory Status

Discontinued

2014
07 Apr
Discontinued Application: 90651

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2014-04-07

90651 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

90651

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2014-04-07

Regulatory Status

Discontinued

2002
23 Oct
Discontinued Application: 40464

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2002-10-23

40464 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40464

Product Number

1

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2002-10-23

Regulatory Status

Discontinued

2002
23 Oct
Discontinued Application: 40464

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;10MG

Approval Date

2002-10-23

40464 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40464

Product Number

2

Dosage Form

-

Strength

325MG;10MG

Approval Date

2002-10-23

Regulatory Status

Discontinued

2002
25 Oct
Discontinued Application: 40469

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

750MG;7.5MG

Approval Date

2002-10-25

40469 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40469

Product Number

1

Dosage Form

-

Strength

750MG;7.5MG

Approval Date

2002-10-25

Regulatory Status

Discontinued

2002
06 Nov
Discontinued Application: 40473

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;10MG

Approval Date

2002-11-06

40473 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40473

Product Number

1

Dosage Form

-

Strength

500MG;10MG

Approval Date

2002-11-06

Regulatory Status

Discontinued

2003
02 Jan
Discontinued Application: 40474

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;7.5MG

Approval Date

2003-01-02

40474 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40474

Product Number

1

Dosage Form

-

Strength

650MG;7.5MG

Approval Date

2003-01-02

Regulatory Status

Discontinued

2002
23 Oct
Discontinued Application: 40476

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;10MG

Approval Date

2002-10-23

40476 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40476

Product Number

1

Dosage Form

-

Strength

650MG;10MG

Approval Date

2002-10-23

Regulatory Status

Discontinued

2002
06 Nov
Discontinued Application: 40477

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

2002-11-06

40477 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40477

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

2002-11-06

Regulatory Status

Discontinued

2002
08 Nov
Discontinued Application: 40478

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

2002-11-08

40478 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40478

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

2002-11-08

Regulatory Status

Discontinued

2003
21 May
Discontinued Application: 40490

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;7.5MG

Approval Date

2003-05-21

40490 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40490

Product Number

1

Dosage Form

-

Strength

500MG;7.5MG

Approval Date

2003-05-21

Regulatory Status

Discontinued

2007
16 Aug
Discontinued Application: 40826

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;10MG

Approval Date

2007-08-16

40826 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40826

Product Number

1

Dosage Form

-

Strength

325MG;10MG

Approval Date

2007-08-16

Regulatory Status

Discontinued

2008
23 Dec
Discontinued Application: 90118

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

2008-12-23

90118 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

90118

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

2008-12-23

Regulatory Status

Discontinued

2008
23 Dec
Discontinued Application: 90118

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2008-12-23

90118 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

90118

Product Number

2

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2008-12-23

Regulatory Status

Discontinued

2008
23 Dec
Discontinued Application: 90118

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

325MG;10MG

Approval Date

2008-12-23

90118 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

90118

Product Number

3

Dosage Form

-

Strength

325MG;10MG

Approval Date

2008-12-23

Regulatory Status

Discontinued

2013
28 May
Discontinued Application: 91633

Drug Name

HYDROCODONE BITARTRATE AND IBUPROFEN

Product Number

1

Dosage Form

-

Strength

2.5MG;200MG

Approval Date

2013-05-28

91633 / 1

Active Ingredient

HYDROCODONE BITARTRATE; IBUPROFEN

Application Number

91633

Product Number

1

Dosage Form

-

Strength

2.5MG;200MG

Approval Date

2013-05-28

Regulatory Status

Discontinued

2013
28 May
Discontinued Application: 91633

Drug Name

HYDROCODONE BITARTRATE AND IBUPROFEN

Product Number

2

Dosage Form

-

Strength

5MG;200MG

Approval Date

2013-05-28

91633 / 2

Active Ingredient

HYDROCODONE BITARTRATE; IBUPROFEN

Application Number

91633

Product Number

2

Dosage Form

-

Strength

5MG;200MG

Approval Date

2013-05-28

Regulatory Status

Discontinued

2013
28 May
Discontinued Application: 91633

Drug Name

HYDROCODONE BITARTRATE AND IBUPROFEN

Product Number

3

Dosage Form

-

Strength

7.5MG;200MG

Approval Date

2013-05-28

91633 / 3

Active Ingredient

HYDROCODONE BITARTRATE; IBUPROFEN

Application Number

91633

Product Number

3

Dosage Form

-

Strength

7.5MG;200MG

Approval Date

2013-05-28

Regulatory Status

Discontinued

2013
28 May
Discontinued Application: 91633

Drug Name

HYDROCODONE BITARTRATE AND IBUPROFEN

Product Number

4

Dosage Form

-

Strength

10MG;200MG

Approval Date

2013-05-28

91633 / 4

Active Ingredient

HYDROCODONE BITARTRATE; IBUPROFEN

Application Number

91633

Product Number

4

Dosage Form

-

Strength

10MG;200MG

Approval Date

2013-05-28

Regulatory Status

Discontinued

2004
22 Jul
Discontinued Application: 40559

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2004-07-22

40559 / 1

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

40559

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2004-07-22

Regulatory Status

Discontinued

2004
22 Jul
Discontinued Application: 40562

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2004-07-22

40562 / 1

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

40562

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2004-07-22

Regulatory Status

Discontinued

2004
22 Jul
Discontinued Application: 40563

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-07-22

40563 / 1

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

40563

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-07-22

Regulatory Status

Discontinued

2008
10 Jun
Discontinued Application: 40899

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2008-06-10

40899 / 1

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

40899

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2008-06-10

Regulatory Status

Discontinued

2008
10 Jun
Discontinued Application: 40899

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2008-06-10

40899 / 2

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

40899

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2008-06-10

Regulatory Status

Discontinued

2008
10 Jun
Discontinued Application: 40899

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2008-06-10

40899 / 3

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

40899

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2008-06-10

Regulatory Status

Discontinued

2014
14 Feb
Discontinued Application: 90853

Drug Name

IBANDRONATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 3MG BASE/3ML

Approval Date

2014-02-14

90853 / 1

Active Ingredient

IBANDRONATE SODIUM

Application Number

90853

Product Number

1

Dosage Form

-

Strength

EQ 3MG BASE/3ML

Approval Date

2014-02-14

Regulatory Status

Discontinued

2015
03 Dec
Discontinued Application: 78340

Drug Name

IMATINIB MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2015-12-03

78340 / 1

Active Ingredient

IMATINIB MESYLATE

Application Number

78340

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2015-12-03

Regulatory Status

Discontinued

2015
03 Dec
Discontinued Application: 78340

Drug Name

IMATINIB MESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2015-12-03

78340 / 2

Active Ingredient

IMATINIB MESYLATE

Application Number

78340

Product Number

2

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2015-12-03

Regulatory Status

Discontinued

2024
01 Jul
Discontinued Application: 212785

Drug Name

INDIUM IN-111 PENTETREOTIDE KIT

Product Number

1

Dosage Form

-

Strength

3mCi/ML

Approval Date

2024-07-01

212785 / 1

Active Ingredient

INDIUM IN-111 PENTETREOTIDE KIT

Application Number

212785

Product Number

1

Dosage Form

-

Strength

3mCi/ML

Approval Date

2024-07-01

Regulatory Status

Discontinued

2002
06 Feb
Discontinued Application: 76114

Drug Name

INDOMETHACIN

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2002-02-06

76114 / 1

Active Ingredient

INDOMETHACIN

Application Number

76114

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2002-02-06

Regulatory Status

Discontinued

2003
17 Dec
Discontinued Application: 76666

Drug Name

INDOMETHACIN

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2003-12-17

76666 / 1

Active Ingredient

INDOMETHACIN

Application Number

76666

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2003-12-17

Regulatory Status

Discontinued

2003
17 Dec
Discontinued Application: 76666

Drug Name

INDOMETHACIN

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2003-12-17

76666 / 2

Active Ingredient

INDOMETHACIN

Application Number

76666

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2003-12-17

Regulatory Status

Discontinued

2013
28 Mar
Discontinued Application: 91401

Drug Name

INDOMETHACIN

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2013-03-28

91401 / 1

Active Ingredient

INDOMETHACIN

Application Number

91401

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2013-03-28

Regulatory Status

Discontinued

2013
28 Mar
Discontinued Application: 91401

Drug Name

INDOMETHACIN

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2013-03-28

91401 / 2

Active Ingredient

INDOMETHACIN

Application Number

91401

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2013-03-28

Regulatory Status

Discontinued

2018
16 Jul
Discontinued Application: 208313

Drug Name

INFUGEM

Product Number

1

Dosage Form

-

Strength

EQ 1200MG BASE/120ML (EQ 10MG BASE/ML)

Approval Date

2018-07-16

208313 / 1

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

208313

Product Number

1

Dosage Form

-

Strength

EQ 1200MG BASE/120ML (EQ 10MG BASE/ML)

Approval Date

2018-07-16

Regulatory Status

Discontinued

2018
16 Jul
Discontinued Application: 208313

Drug Name

INFUGEM

Product Number

2

Dosage Form

-

Strength

EQ 1300MG BASE/130ML (EQ 10MG BASE/ML)

Approval Date

2018-07-16

208313 / 2

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

208313

Product Number

2

Dosage Form

-

Strength

EQ 1300MG BASE/130ML (EQ 10MG BASE/ML)

Approval Date

2018-07-16

Regulatory Status

Discontinued

2018
16 Jul
Discontinued Application: 208313

Drug Name

INFUGEM

Product Number

3

Dosage Form

-

Strength

EQ 1400MG BASE/140ML (EQ 10MG BASE/ML)

Approval Date

2018-07-16

208313 / 3

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

208313

Product Number

3

Dosage Form

-

Strength

EQ 1400MG BASE/140ML (EQ 10MG BASE/ML)

Approval Date

2018-07-16

Regulatory Status

Discontinued

2018
16 Jul
Discontinued Application: 208313

Drug Name

INFUGEM

Product Number

4

Dosage Form

-

Strength

EQ 1500MG BASE/150ML (EQ 10MG BASE/ML)

Approval Date

2018-07-16

208313 / 4

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

208313

Product Number

4

Dosage Form

-

Strength

EQ 1500MG BASE/150ML (EQ 10MG BASE/ML)

Approval Date

2018-07-16

Regulatory Status

Discontinued

2018
16 Jul
Discontinued Application: 208313

Drug Name

INFUGEM

Product Number

5

Dosage Form

-

Strength

EQ 1600MG BASE/160ML (EQ 10MG BASE/ML)

Approval Date

2018-07-16

208313 / 5

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

208313

Product Number

5

Dosage Form

-

Strength

EQ 1600MG BASE/160ML (EQ 10MG BASE/ML)

Approval Date

2018-07-16

Regulatory Status

Discontinued

2018
16 Jul
Discontinued Application: 208313

Drug Name

INFUGEM

Product Number

6

Dosage Form

-

Strength

EQ 1700MG BASE/170ML (EQ 10MG BASE/ML)

Approval Date

2018-07-16

208313 / 6

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

208313

Product Number

6

Dosage Form

-

Strength

EQ 1700MG BASE/170ML (EQ 10MG BASE/ML)

Approval Date

2018-07-16

Regulatory Status

Discontinued

2018
16 Jul
Discontinued Application: 208313

Drug Name

INFUGEM

Product Number

7

Dosage Form

-

Strength

EQ 1800MG BASE/180ML (EQ 10MG BASE/ML)

Approval Date

2018-07-16

208313 / 7

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

208313

Product Number

7

Dosage Form

-

Strength

EQ 1800MG BASE/180ML (EQ 10MG BASE/ML)

Approval Date

2018-07-16

Regulatory Status

Discontinued

2018
16 Jul
Discontinued Application: 208313

Drug Name

INFUGEM

Product Number

8

Dosage Form

-

Strength

EQ 1900MG BASE/190ML (EQ 10MG BASE/ML)

Approval Date

2018-07-16

208313 / 8

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

208313

Product Number

8

Dosage Form

-

Strength

EQ 1900MG BASE/190ML (EQ 10MG BASE/ML)

Approval Date

2018-07-16

Regulatory Status

Discontinued

2018
16 Jul
Discontinued Application: 208313

Drug Name

INFUGEM

Product Number

9

Dosage Form

-

Strength

EQ 2000MG BASE/200ML (EQ 10MG BASE/ML)

Approval Date

2018-07-16

208313 / 9

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

208313

Product Number

9

Dosage Form

-

Strength

EQ 2000MG BASE/200ML (EQ 10MG BASE/ML)

Approval Date

2018-07-16

Regulatory Status

Discontinued

2018
16 Jul
Discontinued Application: 208313

Drug Name

INFUGEM

Product Number

10

Dosage Form

-

Strength

EQ 2200MG BASE/220ML (EQ 10MG BASE/ML)

Approval Date

2018-07-16

208313 / 10

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

208313

Product Number

10

Dosage Form

-

Strength

EQ 2200MG BASE/220ML (EQ 10MG BASE/ML)

Approval Date

2018-07-16

Regulatory Status

Discontinued

1994
25 Mar
Discontinued Application: 20084

Drug Name

IOBENGUANE SULFATE I 131

Product Number

1

Dosage Form

-

Strength

2.3mCi/ML

Approval Date

1994-03-25

20084 / 1

Active Ingredient

IOBENGUANE SULFATE I-131

Application Number

20084

Product Number

1

Dosage Form

-

Strength

2.3mCi/ML

Approval Date

1994-03-25

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17313

Drug Name

IODOHIPPURATE SODIUM I 131

Product Number

1

Dosage Form

-

Strength

0.2mCi/ML

Approval Date

1982-01-01

17313 / 1

Active Ingredient

IODOHIPPURATE SODIUM I-131

Application Number

17313

Product Number

1

Dosage Form

-

Strength

0.2mCi/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2017
03 Jan
Discontinued Application: 207903

Drug Name

IPRATROPIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

0.02%

Approval Date

2017-01-03

207903 / 1

Active Ingredient

IPRATROPIUM BROMIDE

Application Number

207903

Product Number

1

Dosage Form

-

Strength

0.02%

Approval Date

2017-01-03

Regulatory Status

Discontinued

2008
21 Apr
Discontinued Application: 78805

Drug Name

IRINOTECAN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

40MG/2ML (20MG/ML)

Approval Date

2008-04-21

78805 / 1

Active Ingredient

IRINOTECAN HYDROCHLORIDE

Application Number

78805

Product Number

1

Dosage Form

-

Strength

40MG/2ML (20MG/ML)

Approval Date

2008-04-21

Regulatory Status

Discontinued

2008
21 Apr
Discontinued Application: 78805

Drug Name

IRINOTECAN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG/5ML (20MG/ML)

Approval Date

2008-04-21

78805 / 2

Active Ingredient

IRINOTECAN HYDROCHLORIDE

Application Number

78805

Product Number

2

Dosage Form

-

Strength

100MG/5ML (20MG/ML)

Approval Date

2008-04-21

Regulatory Status

Discontinued

1998
30 Dec
Discontinued Application: 40009

Drug Name

ISOSORBIDE DINITRATE

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1998-12-30

40009 / 1

Active Ingredient

ISOSORBIDE DINITRATE

Application Number

40009

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1998-12-30

Regulatory Status

Discontinued

2019
13 Mar
Discontinued Application: 202138

Drug Name

KEMEYA

Product Number

1

Dosage Form

-

Strength

3MG;0.03MG

Approval Date

2019-03-13

202138 / 1

Active Ingredient

DROSPIRENONE; ETHINYL ESTRADIOL

Application Number

202138

Product Number

1

Dosage Form

-

Strength

3MG;0.03MG

Approval Date

2019-03-13

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 12104

Drug Name

KENALOG

Product Number

1

Dosage Form

-

Strength

0.147MG/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

12104 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

12104

Product Number

1

Dosage Form

-

Strength

0.147MG/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

2008
06 Oct
Discontinued Application: 78737

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

15MG/ML

Approval Date

2008-10-06

78737 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

78737

Product Number

1

Dosage Form

-

Strength

15MG/ML

Approval Date

2008-10-06

Regulatory Status

Discontinued

2008
06 Oct
Discontinued Application: 78737

Drug Name

KETOROLAC TROMETHAMINE

Product Number

2

Dosage Form

-

Strength

30MG/ML

Approval Date

2008-10-06

78737 / 2

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

78737

Product Number

2

Dosage Form

-

Strength

30MG/ML

Approval Date

2008-10-06

Regulatory Status

Discontinued

2009
05 Nov
Discontinued Application: 90017

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2009-11-05

90017 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

90017

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2009-11-05

Regulatory Status

Discontinued

2019
23 Jul
Discontinued Application: 202318

Drug Name

KYRA

Product Number

1

Dosage Form

-

Strength

3MG;0.02MG

Approval Date

2019-07-23

202318 / 1

Active Ingredient

DROSPIRENONE; ETHINYL ESTRADIOL

Application Number

202318

Product Number

1

Dosage Form

-

Strength

3MG;0.02MG

Approval Date

2019-07-23

Regulatory Status

Discontinued

1985
24 Apr
Discontinued Application: 19155

Drug Name

LAC-HYDRIN

Product Number

1

Dosage Form

-

Strength

EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-04-24

19155 / 1

Active Ingredient

AMMONIUM LACTATE

Application Number

19155

Product Number

1

Dosage Form

-

Strength

EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-04-24

Regulatory Status

Discontinued

1996
29 Aug
Discontinued Application: 20508

Drug Name

LAC-HYDRIN

Product Number

1

Dosage Form

-

Strength

EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-08-29

20508 / 1

Active Ingredient

AMMONIUM LACTATE

Application Number

20508

Product Number

1

Dosage Form

-

Strength

EQ 12% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-08-29

Regulatory Status

Discontinued

2013
13 Sep
Discontinued Application: 91509

Drug Name

LANSOPRAZOLE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2013-09-13

91509 / 1

Active Ingredient

LANSOPRAZOLE

Application Number

91509

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2013-09-13

Regulatory Status

Discontinued

2013
13 Sep
Discontinued Application: 202637

Drug Name

LANSOPRAZOLE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2013-09-13

202637 / 1

Active Ingredient

LANSOPRAZOLE

Application Number

202637

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2013-09-13

Regulatory Status

Discontinued

2011
03 Jun
Discontinued Application: 91466

Drug Name

LETROZOLE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2011-06-03

91466 / 1

Active Ingredient

LETROZOLE

Application Number

91466

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2011-06-03

Regulatory Status

Discontinued

2018
05 Nov
Discontinued Application: 207820

Drug Name

LEVALBUTEROL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.0103% BASE

Approval Date

2018-11-05

207820 / 1

Active Ingredient

LEVALBUTEROL HYDROCHLORIDE

Application Number

207820

Product Number

1

Dosage Form

-

Strength

EQ 0.0103% BASE

Approval Date

2018-11-05

Regulatory Status

Discontinued

2018
05 Nov
Discontinued Application: 207820

Drug Name

LEVALBUTEROL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 0.021% BASE

Approval Date

2018-11-05

207820 / 2

Active Ingredient

LEVALBUTEROL HYDROCHLORIDE

Application Number

207820

Product Number

2

Dosage Form

-

Strength

EQ 0.021% BASE

Approval Date

2018-11-05

Regulatory Status

Discontinued

2018
05 Nov
Discontinued Application: 207820

Drug Name

LEVALBUTEROL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 0.042% BASE

Approval Date

2018-11-05

207820 / 3

Active Ingredient

LEVALBUTEROL HYDROCHLORIDE

Application Number

207820

Product Number

3

Dosage Form

-

Strength

EQ 0.042% BASE

Approval Date

2018-11-05

Regulatory Status

Discontinued

2010
16 Jun
Discontinued Application: 90754

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

500MG/5ML (100MG/ML)

Approval Date

2010-06-16

90754 / 1

Active Ingredient

LEVETIRACETAM

Application Number

90754

Product Number

1

Dosage Form

-

Strength

500MG/5ML (100MG/ML)

Approval Date

2010-06-16

Regulatory Status

Discontinued

2013
09 Sep
Discontinued Application: 203059

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2013-09-09

203059 / 1

Active Ingredient

LEVETIRACETAM

Application Number

203059

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2013-09-09

Regulatory Status

Discontinued

2013
09 Sep
Discontinued Application: 203059

Drug Name

LEVETIRACETAM

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2013-09-09

203059 / 2

Active Ingredient

LEVETIRACETAM

Application Number

203059

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2013-09-09

Regulatory Status

Discontinued

2015
26 Jun
Discontinued Application: 201653

Drug Name

LEVOCETIRIZINE DIHYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-06-26

201653 / 1

Active Ingredient

LEVOCETIRIZINE DIHYDROCHLORIDE

Application Number

201653

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-06-26

Regulatory Status

Discontinued

2001
27 Sep
Discontinued Application: 76121

Drug Name

LITHIUM CARBONATE

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2001-09-27

76121 / 1

Active Ingredient

LITHIUM CARBONATE

Application Number

76121

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2001-09-27

Regulatory Status

Discontinued

2003
21 Apr
Discontinued Application: 76382

Drug Name

LITHIUM CARBONATE

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2003-04-21

76382 / 1

Active Ingredient

LITHIUM CARBONATE

Application Number

76382

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2003-04-21

Regulatory Status

Discontinued

2004
29 Jun
Discontinued Application: 76823

Drug Name

LITHIUM CARBONATE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2004-06-29

76823 / 1

Active Ingredient

LITHIUM CARBONATE

Application Number

76823

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2004-06-29

Regulatory Status

Discontinued

2004
29 Jun
Discontinued Application: 76823

Drug Name

LITHIUM CARBONATE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2004-06-29

76823 / 2

Active Ingredient

LITHIUM CARBONATE

Application Number

76823

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2004-06-29

Regulatory Status

Discontinued

2004
29 Jun
Discontinued Application: 76823

Drug Name

LITHIUM CARBONATE

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2004-06-29

76823 / 3

Active Ingredient

LITHIUM CARBONATE

Application Number

76823

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2004-06-29

Regulatory Status

Discontinued

2010
24 Jun
Discontinued Application: 91027

Drug Name

LITHIUM CARBONATE

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2010-06-24

91027 / 1

Active Ingredient

LITHIUM CARBONATE

Application Number

91027

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2010-06-24

Regulatory Status

Discontinued

1993
30 Nov
Discontinued Application: 73528

Drug Name

LOPERAMIDE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1993-11-30

73528 / 1

Active Ingredient

LOPERAMIDE HYDROCHLORIDE

Application Number

73528

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1993-11-30

Regulatory Status

Discontinued

2006
06 Sep
Discontinued Application: 77500

Drug Name

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE

Product Number

1

Dosage Form

-

Strength

2MG;125MG

Approval Date

2006-09-06

77500 / 1

Active Ingredient

LOPERAMIDE HYDROCHLORIDE; SIMETHICONE

Application Number

77500

Product Number

1

Dosage Form

-

Strength

2MG;125MG

Approval Date

2006-09-06

Regulatory Status

Discontinued

2023
09 Aug
Discontinued Application: 215384

Drug Name

LOTEPREDNOL ETABONATE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2023-08-09

215384 / 1

Active Ingredient

LOTEPREDNOL ETABONATE

Application Number

215384

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2023-08-09

Regulatory Status

Discontinued

2019
04 Jan
Discontinued Application: 208066

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

120MG

Approval Date

2019-01-04

208066 / 5

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

208066

Product Number

5

Dosage Form

-

Strength

120MG

Approval Date

2019-01-04

Regulatory Status

Discontinued

2019
01 May
Discontinued Application: 210760

Drug Name

MEDROXYPROGESTERONE ACETATE

Product Number

1

Dosage Form

-

Strength

150MG/ML

Approval Date

2019-05-01

210760 / 1

Active Ingredient

MEDROXYPROGESTERONE ACETATE

Application Number

210760

Product Number

1

Dosage Form

-

Strength

150MG/ML

Approval Date

2019-05-01

Regulatory Status

Discontinued

2019
24 Apr
Discontinued Application: 210761

Drug Name

MEDROXYPROGESTERONE ACETATE

Product Number

1

Dosage Form

-

Strength

150MG/ML

Approval Date

2019-04-24

210761 / 1

Active Ingredient

MEDROXYPROGESTERONE ACETATE

Application Number

210761

Product Number

1

Dosage Form

-

Strength

150MG/ML

Approval Date

2019-04-24

Regulatory Status

Discontinued

2006
19 Jul
Discontinued Application: 77937

Drug Name

MELOXICAM

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2006-07-19

77937 / 1

Active Ingredient

MELOXICAM

Application Number

77937

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2006-07-19

Regulatory Status

Discontinued

2006
19 Jul
Discontinued Application: 77937

Drug Name

MELOXICAM

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2006-07-19

77937 / 2

Active Ingredient

MELOXICAM

Application Number

77937

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2006-07-19

Regulatory Status

Discontinued

2016
28 Sep
Discontinued Application: 205905

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

7MG

Approval Date

2016-09-28

205905 / 1

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

205905

Product Number

1

Dosage Form

-

Strength

7MG

Approval Date

2016-09-28

Regulatory Status

Discontinued

2016
28 Sep
Discontinued Application: 205905

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

14MG

Approval Date

2016-09-28

205905 / 2

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

205905

Product Number

2

Dosage Form

-

Strength

14MG

Approval Date

2016-09-28

Regulatory Status

Discontinued

2016
28 Sep
Discontinued Application: 205905

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

21MG

Approval Date

2016-09-28

205905 / 3

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

205905

Product Number

3

Dosage Form

-

Strength

21MG

Approval Date

2016-09-28

Regulatory Status

Discontinued

2016
28 Sep
Discontinued Application: 205905

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

28MG

Approval Date

2016-09-28

205905 / 4

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

205905

Product Number

4

Dosage Form

-

Strength

28MG

Approval Date

2016-09-28

Regulatory Status

Discontinued

2002
08 Aug
Discontinued Application: 40446

Drug Name

MEPERIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2002-08-08

40446 / 1

Active Ingredient

MEPERIDINE HYDROCHLORIDE

Application Number

40446

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2002-08-08

Regulatory Status

Discontinued

2002
08 Aug
Discontinued Application: 40446

Drug Name

MEPERIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2002-08-08

40446 / 2

Active Ingredient

MEPERIDINE HYDROCHLORIDE

Application Number

40446

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2002-08-08

Regulatory Status

Discontinued

2002
29 Jan
Discontinued Application: 75967

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2002-01-29

75967 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

75967

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2002-01-29

Regulatory Status

Discontinued

2002
29 Jan
Discontinued Application: 75967

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

850MG

Approval Date

2002-01-29

75967 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

75967

Product Number

2

Dosage Form

-

Strength

850MG

Approval Date

2002-01-29

Regulatory Status

Discontinued

2002
29 Jan
Discontinued Application: 75967

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

1GM

Approval Date

2002-01-29

75967 / 3

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

75967

Product Number

3

Dosage Form

-

Strength

1GM

Approval Date

2002-01-29

Regulatory Status

Discontinued

2006
09 Feb
Discontinued Application: 77336

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2006-02-09

77336 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

77336

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2006-02-09

Regulatory Status

Discontinued

2006
09 Feb
Discontinued Application: 77336

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2006-02-09

77336 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

77336

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2006-02-09

Regulatory Status

Discontinued

2016
01 Aug
Discontinued Application: 202917

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2016-08-01

202917 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

202917

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2016-08-01

Regulatory Status

Discontinued

2016
01 Aug
Discontinued Application: 202917

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2016-08-01

202917 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

202917

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2016-08-01

Regulatory Status

Discontinued

2004
25 Feb
Discontinued Application: 40529

Drug Name

METHAMPHETAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2004-02-25

40529 / 1

Active Ingredient

METHAMPHETAMINE HYDROCHLORIDE

Application Number

40529

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2004-02-25

Regulatory Status

Discontinued

2007
25 Sep
Discontinued Application: 40870

Drug Name

METHIMAZOLE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-09-25

40870 / 1

Active Ingredient

METHIMAZOLE

Application Number

40870

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-09-25

Regulatory Status

Discontinued

2007
25 Sep
Discontinued Application: 40870

Drug Name

METHIMAZOLE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-09-25

40870 / 2

Active Ingredient

METHIMAZOLE

Application Number

40870

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-09-25

Regulatory Status

Discontinued

2003
17 Mar
Discontinued Application: 40413

Drug Name

METHOCARBAMOL

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2003-03-17

40413 / 1

Active Ingredient

METHOCARBAMOL

Application Number

40413

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2003-03-17

Regulatory Status

Discontinued

2003
17 Mar
Discontinued Application: 40413

Drug Name

METHOCARBAMOL

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2003-03-17

40413 / 2

Active Ingredient

METHOCARBAMOL

Application Number

40413

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2003-03-17

Regulatory Status

Discontinued

2001
29 Mar
Discontinued Application: 40404

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2001-03-29

40404 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

40404

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2001-03-29

Regulatory Status

Discontinued

2001
29 Mar
Discontinued Application: 40404

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2001-03-29

40404 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

40404

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2001-03-29

Regulatory Status

Discontinued

2001
29 Mar
Discontinued Application: 40404

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2001-03-29

40404 / 3

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

40404

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2001-03-29

Regulatory Status

Discontinued

2001
09 May
Discontinued Application: 76032

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2001-05-09

76032 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

76032

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2001-05-09

Regulatory Status

Discontinued

2020
19 Aug
Discontinued Application: 205135

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

18MG

Approval Date

2020-08-19

205135 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

205135

Product Number

1

Dosage Form

-

Strength

18MG

Approval Date

2020-08-19

Regulatory Status

Discontinued

2020
19 Aug
Discontinued Application: 205135

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

27MG

Approval Date

2020-08-19

205135 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

205135

Product Number

2

Dosage Form

-

Strength

27MG

Approval Date

2020-08-19

Regulatory Status

Discontinued

2020
19 Aug
Discontinued Application: 205135

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

36MG

Approval Date

2020-08-19

205135 / 3

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

205135

Product Number

3

Dosage Form

-

Strength

36MG

Approval Date

2020-08-19

Regulatory Status

Discontinued

2020
19 Aug
Discontinued Application: 205135

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

54MG

Approval Date

2020-08-19

205135 / 4

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

205135

Product Number

4

Dosage Form

-

Strength

54MG

Approval Date

2020-08-19

Regulatory Status

Discontinued

2004
15 Jan
Discontinued Application: 76670

Drug Name

METOPROLOL TARTRATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2004-01-15

76670 / 1

Active Ingredient

METOPROLOL TARTRATE

Application Number

76670

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2004-01-15

Regulatory Status

Discontinued

2012
19 Jan
Discontinued Application: 90654

Drug Name

METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

25MG;50MG

Approval Date

2012-01-19

90654 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

Application Number

90654

Product Number

1

Dosage Form

-

Strength

25MG;50MG

Approval Date

2012-01-19

Regulatory Status

Discontinued

2012
19 Jan
Discontinued Application: 90654

Drug Name

METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

25MG;100MG

Approval Date

2012-01-19

90654 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

Application Number

90654

Product Number

2

Dosage Form

-

Strength

25MG;100MG

Approval Date

2012-01-19

Regulatory Status

Discontinued

2012
19 Jan
Discontinued Application: 90654

Drug Name

METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

50MG;100MG

Approval Date

2012-01-19

90654 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE

Application Number

90654

Product Number

3

Dosage Form

-

Strength

50MG;100MG

Approval Date

2012-01-19

Regulatory Status

Discontinued

2003
25 Jun
Discontinued Application: 76462

Drug Name

METRONIDAZOLE

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

2003-06-25

76462 / 1

Active Ingredient

METRONIDAZOLE

Application Number

76462

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

2003-06-25

Regulatory Status

Discontinued

2003
13 Nov
Discontinued Application: 76505

Drug Name

METRONIDAZOLE

Product Number

1

Dosage Form

-

Strength

375MG

Approval Date

2003-11-13

76505 / 1

Active Ingredient

METRONIDAZOLE

Application Number

76505

Product Number

1

Dosage Form

-

Strength

375MG

Approval Date

2003-11-13

Regulatory Status

Discontinued

2003
27 Jun
Discontinued Application: 76519

Drug Name

METRONIDAZOLE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2003-06-27

76519 / 1

Active Ingredient

METRONIDAZOLE

Application Number

76519

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2003-06-27

Regulatory Status

Discontinued

2003
27 Jun
Discontinued Application: 76519

Drug Name

METRONIDAZOLE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2003-06-27

76519 / 2

Active Ingredient

METRONIDAZOLE

Application Number

76519

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2003-06-27

Regulatory Status

Discontinued

2002
15 Mar
Discontinued Application: 76058

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2002-03-15

76058 / 1

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

76058

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2002-03-15

Regulatory Status

Discontinued

2013
13 May
Discontinued Application: 90867

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2013-05-13

90867 / 1

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

90867

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2013-05-13

Regulatory Status

Discontinued

2013
13 May
Discontinued Application: 90867

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2013-05-13

90867 / 2

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

90867

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2013-05-13

Regulatory Status

Discontinued

2013
13 May
Discontinued Application: 90867

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2013-05-13

90867 / 3

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

90867

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2013-05-13

Regulatory Status

Discontinued

2014
25 Sep
Discontinued Application: 91118

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2014-09-25

91118 / 1

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

91118

Product Number

1

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2014-09-25

Regulatory Status

Discontinued

2019
03 Dec
Discontinued Application: 91118

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 65MG BASE

Approval Date

2019-12-03

91118 / 3

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

91118

Product Number

3

Dosage Form

-

Strength

EQ 65MG BASE

Approval Date

2019-12-03

Regulatory Status

Discontinued

2014
25 Sep
Discontinued Application: 91118

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2014-09-25

91118 / 4

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

91118

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2014-09-25

Regulatory Status

Discontinued

2014
25 Sep
Discontinued Application: 91118

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

EQ 90MG BASE

Approval Date

2014-09-25

91118 / 5

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

91118

Product Number

5

Dosage Form

-

Strength

EQ 90MG BASE

Approval Date

2014-09-25

Regulatory Status

Discontinued

2014
25 Sep
Discontinued Application: 91118

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

EQ 105MG BASE

Approval Date

2014-09-25

91118 / 6

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

91118

Product Number

6

Dosage Form

-

Strength

EQ 105MG BASE

Approval Date

2014-09-25

Regulatory Status

Discontinued

2019
03 Dec
Discontinued Application: 91118

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

7

Dosage Form

-

Strength

EQ 115MG BASE

Approval Date

2019-12-03

91118 / 7

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

91118

Product Number

7

Dosage Form

-

Strength

EQ 115MG BASE

Approval Date

2019-12-03

Regulatory Status

Discontinued

2014
25 Sep
Discontinued Application: 91118

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

8

Dosage Form

-

Strength

EQ 135MG BASE

Approval Date

2014-09-25

91118 / 8

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

91118

Product Number

8

Dosage Form

-

Strength

EQ 135MG BASE

Approval Date

2014-09-25

Regulatory Status

Discontinued

2015
30 Dec
Discontinued Application: 204394

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2015-12-30

204394 / 1

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

204394

Product Number

1

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2015-12-30

Regulatory Status

Discontinued

2022
07 Oct
Discontinued Application: 204394

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 55MG BASE

Approval Date

2022-10-07

204394 / 2

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

204394

Product Number

2

Dosage Form

-

Strength

EQ 55MG BASE

Approval Date

2022-10-07

Regulatory Status

Discontinued

2022
07 Oct
Discontinued Application: 204394

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 65MG BASE

Approval Date

2022-10-07

204394 / 3

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

204394

Product Number

3

Dosage Form

-

Strength

EQ 65MG BASE

Approval Date

2022-10-07

Regulatory Status

Discontinued

2015
30 Dec
Discontinued Application: 204394

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2015-12-30

204394 / 4

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

204394

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2015-12-30

Regulatory Status

Discontinued

2015
30 Dec
Discontinued Application: 204394

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

EQ 105MG BASE

Approval Date

2015-12-30

204394 / 5

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

204394

Product Number

5

Dosage Form

-

Strength

EQ 105MG BASE

Approval Date

2015-12-30

Regulatory Status

Discontinued

2022
07 Oct
Discontinued Application: 204394

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

EQ 115MG BASE

Approval Date

2022-10-07

204394 / 6

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

204394

Product Number

6

Dosage Form

-

Strength

EQ 115MG BASE

Approval Date

2022-10-07

Regulatory Status

Discontinued

2015
30 Dec
Discontinued Application: 204394

Drug Name

MINOCYCLINE HYDROCHLORIDE

Product Number

7

Dosage Form

-

Strength

EQ 135MG BASE

Approval Date

2015-12-30

204394 / 7

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

204394

Product Number

7

Dosage Form

-

Strength

EQ 135MG BASE

Approval Date

2015-12-30

Regulatory Status

Discontinued

2003
22 Aug
Discontinued Application: 76544

Drug Name

NAPROXEN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2003-08-22

76544 / 1

Active Ingredient

NAPROXEN SODIUM

Application Number

76544

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2003-08-22

Regulatory Status

Discontinued

2003
22 Aug
Discontinued Application: 76544

Drug Name

NAPROXEN SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2003-08-22

76544 / 2

Active Ingredient

NAPROXEN SODIUM

Application Number

76544

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2003-08-22

Regulatory Status

Discontinued

2011
20 May
Discontinued Application: 91183

Drug Name

NAPROXEN SODIUM

Product Number

1

Dosage Form

-

Strength

220MG

Approval Date

2011-05-20

91183 / 1

Active Ingredient

NAPROXEN SODIUM

Application Number

91183

Product Number

1

Dosage Form

-

Strength

220MG

Approval Date

2011-05-20

Regulatory Status

Discontinued

2011
14 Feb
Discontinued Application: 91552

Drug Name

NARATRIPTAN

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2011-02-14

91552 / 1

Active Ingredient

NARATRIPTAN HYDROCHLORIDE

Application Number

91552

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2011-02-14

Regulatory Status

Discontinued

2003
16 Sep
Discontinued Application: 76409

Drug Name

NEFAZODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2003-09-16

76409 / 1

Active Ingredient

NEFAZODONE HYDROCHLORIDE

Application Number

76409

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2003-09-16

Regulatory Status

Discontinued

2003
16 Sep
Discontinued Application: 76409

Drug Name

NEFAZODONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2003-09-16

76409 / 2

Active Ingredient

NEFAZODONE HYDROCHLORIDE

Application Number

76409

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2003-09-16

Regulatory Status

Discontinued

2003
16 Sep
Discontinued Application: 76409

Drug Name

NEFAZODONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2003-09-16

76409 / 3

Active Ingredient

NEFAZODONE HYDROCHLORIDE

Application Number

76409

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2003-09-16

Regulatory Status

Discontinued

2003
16 Sep
Discontinued Application: 76409

Drug Name

NEFAZODONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2003-09-16

76409 / 4

Active Ingredient

NEFAZODONE HYDROCHLORIDE

Application Number

76409

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2003-09-16

Regulatory Status

Discontinued

2003
16 Sep
Discontinued Application: 76409

Drug Name

NEFAZODONE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

250MG

Approval Date

2003-09-16

76409 / 5

Active Ingredient

NEFAZODONE HYDROCHLORIDE

Application Number

76409

Product Number

5

Dosage Form

-

Strength

250MG

Approval Date

2003-09-16

Regulatory Status

Discontinued

2009
17 Nov
Discontinued Application: 78405

Drug Name

NICARDIPINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG/10ML (2.5MG/ML)

Approval Date

2009-11-17

78405 / 1

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

78405

Product Number

1

Dosage Form

-

Strength

25MG/10ML (2.5MG/ML)

Approval Date

2009-11-17

Regulatory Status

Discontinued

2007
17 Apr
Discontinued Application: 77067

Drug Name

NIMODIPINE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2007-04-17

77067 / 1

Active Ingredient

NIMODIPINE

Application Number

77067

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2007-04-17

Regulatory Status

Discontinued

2021
29 Jan
Discontinued Application: 211980

Drug Name

NOREPINEPHRINE BITARTRATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2021-01-29

211980 / 1

Active Ingredient

NOREPINEPHRINE BITARTRATE

Application Number

211980

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2021-01-29

Regulatory Status

Discontinued

2008
04 Mar
Discontinued Application: 77329

Drug Name

OCTREOTIDE ACETATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

2008-03-04

77329 / 1

Active Ingredient

OCTREOTIDE ACETATE

Application Number

77329

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

2008-03-04

Regulatory Status

Discontinued

2008
04 Mar
Discontinued Application: 77329

Drug Name

OCTREOTIDE ACETATE

Product Number

2

Dosage Form

-

Strength

EQ 0.1MG BASE/ML

Approval Date

2008-03-04

77329 / 2

Active Ingredient

OCTREOTIDE ACETATE

Application Number

77329

Product Number

2

Dosage Form

-

Strength

EQ 0.1MG BASE/ML

Approval Date

2008-03-04

Regulatory Status

Discontinued

2008
04 Mar
Discontinued Application: 77329

Drug Name

OCTREOTIDE ACETATE

Product Number

3

Dosage Form

-

Strength

EQ 0.5MG BASE/ML

Approval Date

2008-03-04

77329 / 3

Active Ingredient

OCTREOTIDE ACETATE

Application Number

77329

Product Number

3

Dosage Form

-

Strength

EQ 0.5MG BASE/ML

Approval Date

2008-03-04

Regulatory Status

Discontinued

2008
04 Mar
Discontinued Application: 77330

Drug Name

OCTREOTIDE ACETATE

Product Number

1

Dosage Form

-

Strength

EQ 0.2MG BASE/ML

Approval Date

2008-03-04

77330 / 1

Active Ingredient

OCTREOTIDE ACETATE

Application Number

77330

Product Number

1

Dosage Form

-

Strength

EQ 0.2MG BASE/ML

Approval Date

2008-03-04

Regulatory Status

Discontinued

2008
04 Mar
Discontinued Application: 77331

Drug Name

OCTREOTIDE ACETATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2008-03-04

77331 / 1

Active Ingredient

OCTREOTIDE ACETATE

Application Number

77331

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2008-03-04

Regulatory Status

Discontinued

2007
14 Aug
Discontinued Application: 77372

Drug Name

OCTREOTIDE ACETATE

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

2007-08-14

77372 / 1

Active Ingredient

OCTREOTIDE ACETATE

Application Number

77372

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

2007-08-14

Regulatory Status

Discontinued

2007
14 Aug
Discontinued Application: 77372

Drug Name

OCTREOTIDE ACETATE

Product Number

2

Dosage Form

-

Strength

EQ 0.1MG BASE/ML

Approval Date

2007-08-14

77372 / 2

Active Ingredient

OCTREOTIDE ACETATE

Application Number

77372

Product Number

2

Dosage Form

-

Strength

EQ 0.1MG BASE/ML

Approval Date

2007-08-14

Regulatory Status

Discontinued

2007
14 Aug
Discontinued Application: 77372

Drug Name

OCTREOTIDE ACETATE

Product Number

3

Dosage Form

-

Strength

EQ 0.5MG BASE/ML

Approval Date

2007-08-14

77372 / 3

Active Ingredient

OCTREOTIDE ACETATE

Application Number

77372

Product Number

3

Dosage Form

-

Strength

EQ 0.5MG BASE/ML

Approval Date

2007-08-14

Regulatory Status

Discontinued

2007
14 Aug
Discontinued Application: 77373

Drug Name

OCTREOTIDE ACETATE

Product Number

1

Dosage Form

-

Strength

EQ 0.2MG BASE/ML

Approval Date

2007-08-14

77373 / 1

Active Ingredient

OCTREOTIDE ACETATE

Application Number

77373

Product Number

1

Dosage Form

-

Strength

EQ 0.2MG BASE/ML

Approval Date

2007-08-14

Regulatory Status

Discontinued

2007
14 Aug
Discontinued Application: 77373

Drug Name

OCTREOTIDE ACETATE

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2007-08-14

77373 / 2

Active Ingredient

OCTREOTIDE ACETATE

Application Number

77373

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2007-08-14

Regulatory Status

Discontinued

2012
28 Feb
Discontinued Application: 90881

Drug Name

OLANZAPINE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2012-02-28

90881 / 1

Active Ingredient

OLANZAPINE

Application Number

90881

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2012-02-28

Regulatory Status

Discontinued

2012
28 Feb
Discontinued Application: 90881

Drug Name

OLANZAPINE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2012-02-28

90881 / 2

Active Ingredient

OLANZAPINE

Application Number

90881

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2012-02-28

Regulatory Status

Discontinued

2012
28 Feb
Discontinued Application: 90881

Drug Name

OLANZAPINE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2012-02-28

90881 / 3

Active Ingredient

OLANZAPINE

Application Number

90881

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2012-02-28

Regulatory Status

Discontinued

2012
28 Feb
Discontinued Application: 90881

Drug Name

OLANZAPINE

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2012-02-28

90881 / 4

Active Ingredient

OLANZAPINE

Application Number

90881

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2012-02-28

Regulatory Status

Discontinued

2012
23 Apr
Discontinued Application: 91038

Drug Name

OLANZAPINE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2012-04-23

91038 / 1

Active Ingredient

OLANZAPINE

Application Number

91038

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2012-04-23

Regulatory Status

Discontinued

2012
23 Apr
Discontinued Application: 91038

Drug Name

OLANZAPINE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2012-04-23

91038 / 2

Active Ingredient

OLANZAPINE

Application Number

91038

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2012-04-23

Regulatory Status

Discontinued

2012
23 Apr
Discontinued Application: 91038

Drug Name

OLANZAPINE

Product Number

3

Dosage Form

-

Strength

7.5MG

Approval Date

2012-04-23

91038 / 3

Active Ingredient

OLANZAPINE

Application Number

91038

Product Number

3

Dosage Form

-

Strength

7.5MG

Approval Date

2012-04-23

Regulatory Status

Discontinued

2012
23 Apr
Discontinued Application: 91038

Drug Name

OLANZAPINE

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2012-04-23

91038 / 4

Active Ingredient

OLANZAPINE

Application Number

91038

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2012-04-23

Regulatory Status

Discontinued

2012
23 Apr
Discontinued Application: 91038

Drug Name

OLANZAPINE

Product Number

5

Dosage Form

-

Strength

15MG

Approval Date

2012-04-23

91038 / 5

Active Ingredient

OLANZAPINE

Application Number

91038

Product Number

5

Dosage Form

-

Strength

15MG

Approval Date

2012-04-23

Regulatory Status

Discontinued

2012
23 Apr
Discontinued Application: 91038

Drug Name

OLANZAPINE

Product Number

6

Dosage Form

-

Strength

20MG

Approval Date

2012-04-23

91038 / 6

Active Ingredient

OLANZAPINE

Application Number

91038

Product Number

6

Dosage Form

-

Strength

20MG

Approval Date

2012-04-23

Regulatory Status

Discontinued

2020
09 Jan
Discontinued Application: 210834

Drug Name

OMEGA-3-ACID ETHYL ESTERS

Product Number

1

Dosage Form

-

Strength

1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS

Approval Date

2020-01-09

210834 / 1

Active Ingredient

OMEGA-3-ACID ETHYL ESTERS

Application Number

210834

Product Number

1

Dosage Form

-

Strength

1GM CONTAINS AT LEAST 900MG OF THE ETHYL ESTERS OF OMEGA-3 FATTY ACIDS

Approval Date

2020-01-09

Regulatory Status

Discontinued

2011
24 Feb
Discontinued Application: 78602

Drug Name

ONDANSETRON

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

2011-02-24

78602 / 1

Active Ingredient

ONDANSETRON

Application Number

78602

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

2011-02-24

Regulatory Status

Discontinued

2011
24 Feb
Discontinued Application: 78602

Drug Name

ONDANSETRON

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

2011-02-24

78602 / 2

Active Ingredient

ONDANSETRON

Application Number

78602

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

2011-02-24

Regulatory Status

Discontinued

2007
25 Jun
Discontinued Application: 77050

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2007-06-25

77050 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77050

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2007-06-25

Regulatory Status

Discontinued

2007
25 Jun
Discontinued Application: 77050

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2007-06-25

77050 / 2

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77050

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2007-06-25

Regulatory Status

Discontinued

2006
26 Dec
Discontinued Application: 77172

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

77172 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77172

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

Regulatory Status

Discontinued

2006
26 Dec
Discontinued Application: 77173

Drug Name

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

77173 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

77173

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2006-12-26

Regulatory Status

Discontinued

1991
27 Feb
Discontinued Application: 89567

Drug Name

ORTHO-EST

Product Number

1

Dosage Form

-

Strength

0.75MG

Approval Date

1991-02-27

89567 / 1

Active Ingredient

ESTROPIPATE

Application Number

89567

Product Number

1

Dosage Form

-

Strength

0.75MG

Approval Date

1991-02-27

Regulatory Status

Discontinued

1991
17 Jul
Discontinued Application: 89582

Drug Name

ORTHO-EST

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

1991-07-17

89582 / 1

Active Ingredient

ESTROPIPATE

Application Number

89582

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

1991-07-17

Regulatory Status

Discontinued

2019
13 Jun
Discontinued Application: 211929

Drug Name

ORTIKOS

Product Number

1

Dosage Form

-

Strength

6MG

Approval Date

2019-06-13

211929 / 1

Active Ingredient

BUDESONIDE

Application Number

211929

Product Number

1

Dosage Form

-

Strength

6MG

Approval Date

2019-06-13

Regulatory Status

Discontinued

2019
13 Jun
Discontinued Application: 211929

Drug Name

ORTIKOS

Product Number

2

Dosage Form

-

Strength

9MG

Approval Date

2019-06-13

211929 / 2

Active Ingredient

BUDESONIDE

Application Number

211929

Product Number

2

Dosage Form

-

Strength

9MG

Approval Date

2019-06-13

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17972

Drug Name

OSTEOLITE

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

1982-01-01

17972 / 1

Active Ingredient

TECHNETIUM TC-99M MEDRONATE KIT

Application Number

17972

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

1982-01-01

Regulatory Status

Discontinued

2009
07 Aug
Discontinued Application: 78818

Drug Name

OXALIPLATIN

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2009-08-07

78818 / 1

Active Ingredient

OXALIPLATIN

Application Number

78818

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2009-08-07

Regulatory Status

Discontinued

2009
07 Aug
Discontinued Application: 78818

Drug Name

OXALIPLATIN

Product Number

2

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2009-08-07

78818 / 2

Active Ingredient

OXALIPLATIN

Application Number

78818

Product Number

2

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2009-08-07

Regulatory Status

Discontinued

2014
08 Apr
Discontinued Application: 202922

Drug Name

OXALIPLATIN

Product Number

1

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

2014-04-08

202922 / 1

Active Ingredient

OXALIPLATIN

Application Number

202922

Product Number

1

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

2014-04-08

Regulatory Status

Discontinued

2014
08 Apr
Discontinued Application: 202922

Drug Name

OXALIPLATIN

Product Number

2

Dosage Form

-

Strength

100MG/20ML (5MG/ML)

Approval Date

2014-04-08

202922 / 2

Active Ingredient

OXALIPLATIN

Application Number

202922

Product Number

2

Dosage Form

-

Strength

100MG/20ML (5MG/ML)

Approval Date

2014-04-08

Regulatory Status

Discontinued

2019
15 Feb
Discontinued Application: 202922

Drug Name

OXALIPLATIN

Product Number

3

Dosage Form

-

Strength

200MG/40ML (5MG/ML)

Approval Date

2019-02-15

202922 / 3

Active Ingredient

OXALIPLATIN

Application Number

202922

Product Number

3

Dosage Form

-

Strength

200MG/40ML (5MG/ML)

Approval Date

2019-02-15

Regulatory Status

Discontinued

2002
03 Jan
Discontinued Application: 75844

Drug Name

OXAPROZIN

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2002-01-03

75844 / 1

Active Ingredient

OXAPROZIN

Application Number

75844

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2002-01-03

Regulatory Status

Discontinued

2013
26 Dec
Discontinued Application: 90535

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;2.5MG

Approval Date

2013-12-26

90535 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

90535

Product Number

1

Dosage Form

-

Strength

325MG;2.5MG

Approval Date

2013-12-26

Regulatory Status

Discontinued

2013
26 Dec
Discontinued Application: 90535

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;5MG

Approval Date

2013-12-26

90535 / 2

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

90535

Product Number

2

Dosage Form

-

Strength

325MG;5MG

Approval Date

2013-12-26

Regulatory Status

Discontinued

2013
26 Dec
Discontinued Application: 90535

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2013-12-26

90535 / 3

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

90535

Product Number

3

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2013-12-26

Regulatory Status

Discontinued

2013
26 Dec
Discontinued Application: 90535

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

4

Dosage Form

-

Strength

325MG;10MG

Approval Date

2013-12-26

90535 / 4

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

90535

Product Number

4

Dosage Form

-

Strength

325MG;10MG

Approval Date

2013-12-26

Regulatory Status

Discontinued

2009
10 Apr
Discontinued Application: 90659

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2009-04-10

90659 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

90659

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2009-04-10

Regulatory Status

Discontinued

2009
10 Apr
Discontinued Application: 90659

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2009-04-10

90659 / 2

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

90659

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2009-04-10

Regulatory Status

Discontinued

2009
10 Apr
Discontinued Application: 90659

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2009-04-10

90659 / 3

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

90659

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2009-04-10

Regulatory Status

Discontinued

2012
06 Nov
Discontinued Application: 90659

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2012-11-06

90659 / 4

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

90659

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2012-11-06

Regulatory Status

Discontinued

2012
06 Nov
Discontinued Application: 90659

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

10MG

Approval Date

2012-11-06

90659 / 5

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

90659

Product Number

5

Dosage Form

-

Strength

10MG

Approval Date

2012-11-06

Regulatory Status

Discontinued

2015
24 Apr
Discontinued Application: 203506

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-04-24

203506 / 1

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

203506

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-04-24

Regulatory Status

Discontinued

2015
24 Apr
Discontinued Application: 203506

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2015-04-24

203506 / 2

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

203506

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2015-04-24

Regulatory Status

Discontinued

2015
24 Apr
Discontinued Application: 203506

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2015-04-24

203506 / 3

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

203506

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2015-04-24

Regulatory Status

Discontinued

2015
24 Apr
Discontinued Application: 203506

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2015-04-24

203506 / 4

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

203506

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2015-04-24

Regulatory Status

Discontinued

2015
24 Apr
Discontinued Application: 203506

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2015-04-24

203506 / 5

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

203506

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2015-04-24

Regulatory Status

Discontinued

2015
24 Apr
Discontinued Application: 203506

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2015-04-24

203506 / 6

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

203506

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2015-04-24

Regulatory Status

Discontinued

2015
24 Apr
Discontinued Application: 203506

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

7

Dosage Form

-

Strength

40MG

Approval Date

2015-04-24

203506 / 7

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

203506

Product Number

7

Dosage Form

-

Strength

40MG

Approval Date

2015-04-24

Regulatory Status

Discontinued

2008
24 Dec
Discontinued Application: 77703

Drug Name

PAMIDRONATE DISODIUM

Product Number

1

Dosage Form

-

Strength

30MG/VIAL

Approval Date

2008-12-24

77703 / 1

Active Ingredient

PAMIDRONATE DISODIUM

Application Number

77703

Product Number

1

Dosage Form

-

Strength

30MG/VIAL

Approval Date

2008-12-24

Regulatory Status

Discontinued

2008
24 Dec
Discontinued Application: 77703

Drug Name

PAMIDRONATE DISODIUM

Product Number

2

Dosage Form

-

Strength

90MG/VIAL

Approval Date

2008-12-24

77703 / 2

Active Ingredient

PAMIDRONATE DISODIUM

Application Number

77703

Product Number

2

Dosage Form

-

Strength

90MG/VIAL

Approval Date

2008-12-24

Regulatory Status

Discontinued

2007
10 Sep
Discontinued Application: 77058

Drug Name

PANTOPRAZOLE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2007-09-10

77058 / 1

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

77058

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2007-09-10

Regulatory Status

Discontinued

2007
10 Sep
Discontinued Application: 77058

Drug Name

PANTOPRAZOLE SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2007-09-10

77058 / 2

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

77058

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2007-09-10

Regulatory Status

Discontinued

2019
19 Aug
Discontinued Application: 77674

Drug Name

PANTOPRAZOLE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2019-08-19

77674 / 1

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

77674

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2019-08-19

Regulatory Status

Discontinued

2012
02 May
Discontinued Application: 200794

Drug Name

PANTOPRAZOLE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-05-02

200794 / 1

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

200794

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-05-02

Regulatory Status

Discontinued

2012
02 May
Discontinued Application: 200794

Drug Name

PANTOPRAZOLE SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2012-05-02

200794 / 2

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

200794

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2012-05-02

Regulatory Status

Discontinued

1997
30 Jun
Discontinued Application: 64171

Drug Name

PAROMOMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1997-06-30

64171 / 1

Active Ingredient

PAROMOMYCIN SULFATE

Application Number

64171

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

1997-06-30

Regulatory Status

Discontinued

2007
29 Jun
Discontinued Application: 78194

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-06-29

78194 / 1

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

78194

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-06-29

Regulatory Status

Discontinued

2007
29 Jun
Discontinued Application: 78194

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2007-06-29

78194 / 2

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

78194

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2007-06-29

Regulatory Status

Discontinued

2007
29 Jun
Discontinued Application: 78194

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2007-06-29

78194 / 3

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

78194

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2007-06-29

Regulatory Status

Discontinued

2007
29 Jun
Discontinued Application: 78194

Drug Name

PAROXETINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2007-06-29

78194 / 4

Active Ingredient

PAROXETINE HYDROCHLORIDE

Application Number

78194

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2007-06-29

Regulatory Status

Discontinued

2001
30 Aug
Discontinued Application: 40402

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

37.5MG

Approval Date

2001-08-30

40402 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

40402

Product Number

1

Dosage Form

-

Strength

37.5MG

Approval Date

2001-08-30

Regulatory Status

Discontinued

2001
30 Aug
Discontinued Application: 40403

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2001-08-30

40403 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

40403

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2001-08-30

Regulatory Status

Discontinued

2001
30 Aug
Discontinued Application: 40427

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2001-08-30

40427 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

40427

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2001-08-30

Regulatory Status

Discontinued

2003
13 Mar
Discontinued Application: 40497

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2003-03-13

40497 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

40497

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2003-03-13

Regulatory Status

Discontinued

2007
21 Aug
Discontinued Application: 40790

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

37.5MG

Approval Date

2007-08-21

40790 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

40790

Product Number

1

Dosage Form

-

Strength

37.5MG

Approval Date

2007-08-21

Regulatory Status

Discontinued

2013
27 Mar
Discontinued Application: 91683

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2013-03-27

91683 / 1

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

91683

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2013-03-27

Regulatory Status

Discontinued

2013
27 Mar
Discontinued Application: 91683

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2013-03-27

91683 / 2

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

91683

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2013-03-27

Regulatory Status

Discontinued

2013
27 Mar
Discontinued Application: 91683

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

2013-03-27

91683 / 3

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

91683

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

2013-03-27

Regulatory Status

Discontinued

2013
27 Mar
Discontinued Application: 91683

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

0.75MG

Approval Date

2013-03-27

91683 / 4

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

91683

Product Number

4

Dosage Form

-

Strength

0.75MG

Approval Date

2013-03-27

Regulatory Status

Discontinued

2013
27 Mar
Discontinued Application: 91683

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

1MG

Approval Date

2013-03-27

91683 / 5

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

91683

Product Number

5

Dosage Form

-

Strength

1MG

Approval Date

2013-03-27

Regulatory Status

Discontinued

2013
27 Mar
Discontinued Application: 91683

Drug Name

PRAMIPEXOLE DIHYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

1.5MG

Approval Date

2013-03-27

91683 / 6

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

91683

Product Number

6

Dosage Form

-

Strength

1.5MG

Approval Date

2013-03-27

Regulatory Status

Discontinued

2019
29 Nov
Discontinued Application: 91157

Drug Name

PREGABALIN

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2019-11-29

91157 / 1

Active Ingredient

PREGABALIN

Application Number

91157

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2019-11-29

Regulatory Status

Discontinued

2019
29 Nov
Discontinued Application: 91157

Drug Name

PREGABALIN

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2019-11-29

91157 / 2

Active Ingredient

PREGABALIN

Application Number

91157

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2019-11-29

Regulatory Status

Discontinued

2019
29 Nov
Discontinued Application: 91157

Drug Name

PREGABALIN

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2019-11-29

91157 / 3

Active Ingredient

PREGABALIN

Application Number

91157

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2019-11-29

Regulatory Status

Discontinued

2019
29 Nov
Discontinued Application: 91157

Drug Name

PREGABALIN

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2019-11-29

91157 / 4

Active Ingredient

PREGABALIN

Application Number

91157

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2019-11-29

Regulatory Status

Discontinued

2019
29 Nov
Discontinued Application: 91157

Drug Name

PREGABALIN

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2019-11-29

91157 / 5

Active Ingredient

PREGABALIN

Application Number

91157

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2019-11-29

Regulatory Status

Discontinued

2019
29 Nov
Discontinued Application: 91157

Drug Name

PREGABALIN

Product Number

6

Dosage Form

-

Strength

200MG

Approval Date

2019-11-29

91157 / 6

Active Ingredient

PREGABALIN

Application Number

91157

Product Number

6

Dosage Form

-

Strength

200MG

Approval Date

2019-11-29

Regulatory Status

Discontinued

2019
29 Nov
Discontinued Application: 91157

Drug Name

PREGABALIN

Product Number

7

Dosage Form

-

Strength

225MG

Approval Date

2019-11-29

91157 / 7

Active Ingredient

PREGABALIN

Application Number

91157

Product Number

7

Dosage Form

-

Strength

225MG

Approval Date

2019-11-29

Regulatory Status

Discontinued

2019
29 Nov
Discontinued Application: 91157

Drug Name

PREGABALIN

Product Number

8

Dosage Form

-

Strength

300MG

Approval Date

2019-11-29

91157 / 8

Active Ingredient

PREGABALIN

Application Number

91157

Product Number

8

Dosage Form

-

Strength

300MG

Approval Date

2019-11-29

Regulatory Status

Discontinued

2021
13 Apr
Discontinued Application: 211889

Drug Name

PREGABALIN

Product Number

1

Dosage Form

-

Strength

82.5MG

Approval Date

2021-04-13

211889 / 1

Active Ingredient

PREGABALIN

Application Number

211889

Product Number

1

Dosage Form

-

Strength

82.5MG

Approval Date

2021-04-13

Regulatory Status

Discontinued

2021
13 Apr
Discontinued Application: 211889

Drug Name

PREGABALIN

Product Number

2

Dosage Form

-

Strength

165MG

Approval Date

2021-04-13

211889 / 2

Active Ingredient

PREGABALIN

Application Number

211889

Product Number

2

Dosage Form

-

Strength

165MG

Approval Date

2021-04-13

Regulatory Status

Discontinued

2021
13 Apr
Discontinued Application: 211889

Drug Name

PREGABALIN

Product Number

3

Dosage Form

-

Strength

330MG

Approval Date

2021-04-13

211889 / 3

Active Ingredient

PREGABALIN

Application Number

211889

Product Number

3

Dosage Form

-

Strength

330MG

Approval Date

2021-04-13

Regulatory Status

Discontinued

2001
11 Jul
Discontinued Application: 40407

Drug Name

PROCHLORPERAZINE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2001-07-11

40407 / 1

Active Ingredient

PROCHLORPERAZINE

Application Number

40407

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2001-07-11

Regulatory Status

Discontinued

2001
11 Jul
Discontinued Application: 40407

Drug Name

PROCHLORPERAZINE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2001-07-11

40407 / 2

Active Ingredient

PROCHLORPERAZINE

Application Number

40407

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2001-07-11

Regulatory Status

Discontinued

2001
11 Jul
Discontinued Application: 40407

Drug Name

PROCHLORPERAZINE

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

2001-07-11

40407 / 3

Active Ingredient

PROCHLORPERAZINE

Application Number

40407

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

2001-07-11

Regulatory Status

Discontinued

2003
27 Feb
Discontinued Application: 40449

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2003-02-27

40449 / 1

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

40449

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2003-02-27

Regulatory Status

Discontinued

2003
11 Apr
Discontinued Application: 40504

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2003-04-11

40504 / 1

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

40504

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2003-04-11

Regulatory Status

Discontinued

2003
11 Apr
Discontinued Application: 40504

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2003-04-11

40504 / 2

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

40504

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2003-04-11

Regulatory Status

Discontinued

2004
01 Jul
Discontinued Application: 40558

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2004-07-01

40558 / 1

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

40558

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2004-07-01

Regulatory Status

Discontinued

2004
01 Jul
Discontinued Application: 40558

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2004-07-01

40558 / 2

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

40558

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2004-07-01

Regulatory Status

Discontinued

2004
01 Jul
Discontinued Application: 40558

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2004-07-01

40558 / 3

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

40558

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2004-07-01

Regulatory Status

Discontinued

2008
30 Dec
Discontinued Application: 40863

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2008-12-30

40863 / 1

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

40863

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2008-12-30

Regulatory Status

Discontinued

2008
30 Dec
Discontinued Application: 40863

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2008-12-30

40863 / 2

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

40863

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2008-12-30

Regulatory Status

Discontinued

2008
30 Dec
Discontinued Application: 40863

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2008-12-30

40863 / 3

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

40863

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2008-12-30

Regulatory Status

Discontinued

2001
11 Jul
Discontinued Application: 75838

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

2001-07-11

75838 / 1

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Application Number

75838

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

2001-07-11

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17684

Drug Name

PYROLITE

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

1982-01-01

17684 / 1

Active Ingredient

TECHNETIUM TC-99M PYRO/TRIMETA PHOSPHATES KIT

Application Number

17684

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

1982-01-01

Regulatory Status

Discontinued

2012
27 Mar
Discontinued Application: 201190

Drug Name

QUETIAPINE FUMARATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2012-03-27

201190 / 1

Active Ingredient

QUETIAPINE FUMARATE

Application Number

201190

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2012-03-27

Regulatory Status

Discontinued

2012
27 Mar
Discontinued Application: 201190

Drug Name

QUETIAPINE FUMARATE

Product Number

4

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2012-03-27

201190 / 4

Active Ingredient

QUETIAPINE FUMARATE

Application Number

201190

Product Number

4

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2012-03-27

Regulatory Status

Discontinued

2012
27 Mar
Discontinued Application: 201190

Drug Name

QUETIAPINE FUMARATE

Product Number

6

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2012-03-27

201190 / 6

Active Ingredient

QUETIAPINE FUMARATE

Application Number

201190

Product Number

6

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2012-03-27

Regulatory Status

Discontinued

2004
15 Dec
Discontinued Application: 76607

Drug Name

QUINAPRIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2004-12-15

76607 / 1

Active Ingredient

QUINAPRIL HYDROCHLORIDE

Application Number

76607

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2004-12-15

Regulatory Status

Discontinued

2004
15 Dec
Discontinued Application: 76607

Drug Name

QUINAPRIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2004-12-15

76607 / 2

Active Ingredient

QUINAPRIL HYDROCHLORIDE

Application Number

76607

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2004-12-15

Regulatory Status

Discontinued

2004
15 Dec
Discontinued Application: 76607

Drug Name

QUINAPRIL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2004-12-15

76607 / 3

Active Ingredient

QUINAPRIL HYDROCHLORIDE

Application Number

76607

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2004-12-15

Regulatory Status

Discontinued

2004
15 Dec
Discontinued Application: 76607

Drug Name

QUINAPRIL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2004-12-15

76607 / 4

Active Ingredient

QUINAPRIL HYDROCHLORIDE

Application Number

76607

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2004-12-15

Regulatory Status

Discontinued

2009
18 Jun
Discontinued Application: 90800

Drug Name

QUINAPRIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2009-06-18

90800 / 1

Active Ingredient

QUINAPRIL HYDROCHLORIDE

Application Number

90800

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2009-06-18

Regulatory Status

Discontinued

2009
18 Jun
Discontinued Application: 90800

Drug Name

QUINAPRIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2009-06-18

90800 / 2

Active Ingredient

QUINAPRIL HYDROCHLORIDE

Application Number

90800

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2009-06-18

Regulatory Status

Discontinued

2009
18 Jun
Discontinued Application: 90800

Drug Name

QUINAPRIL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2009-06-18

90800 / 3

Active Ingredient

QUINAPRIL HYDROCHLORIDE

Application Number

90800

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2009-06-18

Regulatory Status

Discontinued

2009
18 Jun
Discontinued Application: 90800

Drug Name

QUINAPRIL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2009-06-18

90800 / 4

Active Ingredient

QUINAPRIL HYDROCHLORIDE

Application Number

90800

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2009-06-18

Regulatory Status

Discontinued

2009
04 Mar
Discontinued Application: 78211

Drug Name

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;EQ 10MG BASE

Approval Date

2009-03-04

78211 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE

Application Number

78211

Product Number

1

Dosage Form

-

Strength

12.5MG;EQ 10MG BASE

Approval Date

2009-03-04

Regulatory Status

Discontinued

2009
04 Mar
Discontinued Application: 78211

Drug Name

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;EQ 20MG BASE

Approval Date

2009-03-04

78211 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE

Application Number

78211

Product Number

2

Dosage Form

-

Strength

12.5MG;EQ 20MG BASE

Approval Date

2009-03-04

Regulatory Status

Discontinued

2009
04 Mar
Discontinued Application: 78211

Drug Name

QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;EQ 20MG BASE

Approval Date

2009-03-04

78211 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE

Application Number

78211

Product Number

3

Dosage Form

-

Strength

25MG;EQ 20MG BASE

Approval Date

2009-03-04

Regulatory Status

Discontinued

2000
14 Jan
Discontinued Application: 75132

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2000-01-14

75132 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

75132

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2000-01-14

Regulatory Status

Discontinued

2000
19 Apr
Discontinued Application: 75439

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2000-04-19

75439 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

75439

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2000-04-19

Regulatory Status

Discontinued

2000
19 Apr
Discontinued Application: 75439

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2000-04-19

75439 / 2

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

75439

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2000-04-19

Regulatory Status

Discontinued

2019
28 May
Discontinued Application: 211707

Drug Name

RANOLAZINE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2019-05-28

211707 / 1

Active Ingredient

RANOLAZINE

Application Number

211707

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2019-05-28

Regulatory Status

Discontinued

2019
28 May
Discontinued Application: 211707

Drug Name

RANOLAZINE

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2019-05-28

211707 / 2

Active Ingredient

RANOLAZINE

Application Number

211707

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2019-05-28

Regulatory Status

Discontinued

2013
11 Jul
Discontinued Application: 77571

Drug Name

REPAGLINIDE

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2013-07-11

77571 / 2

Active Ingredient

REPAGLINIDE

Application Number

77571

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2013-07-11

Regulatory Status

Discontinued

2013
11 Jul
Discontinued Application: 77571

Drug Name

REPAGLINIDE

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2013-07-11

77571 / 3

Active Ingredient

REPAGLINIDE

Application Number

77571

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2013-07-11

Regulatory Status

Discontinued

2013
18 Jun
Discontinued Application: 91417

Drug Name

RILUZOLE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2013-06-18

91417 / 1

Active Ingredient

RILUZOLE

Application Number

91417

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2013-06-18

Regulatory Status

Discontinued

2019
29 Aug
Discontinued Application: 212595

Drug Name

RIOMET ER

Product Number

1

Dosage Form

-

Strength

500MG/5ML

Approval Date

2019-08-29

212595 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

212595

Product Number

1

Dosage Form

-

Strength

500MG/5ML

Approval Date

2019-08-29

Regulatory Status

Discontinued

2019
09 Jul
Discontinued Application: 203925

Drug Name

RISEDRONATE SODIUM

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

2019-07-09

203925 / 1

Active Ingredient

RISEDRONATE SODIUM

Application Number

203925

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

2019-07-09

Regulatory Status

Discontinued

2014
10 Mar
Discontinued Application: 78036

Drug Name

RISPERIDONE

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2014-03-10

78036 / 1

Active Ingredient

RISPERIDONE

Application Number

78036

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2014-03-10

Regulatory Status

Discontinued

2014
10 Mar
Discontinued Application: 78036

Drug Name

RISPERIDONE

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2014-03-10

78036 / 2

Active Ingredient

RISPERIDONE

Application Number

78036

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2014-03-10

Regulatory Status

Discontinued

2014
10 Mar
Discontinued Application: 78036

Drug Name

RISPERIDONE

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2014-03-10

78036 / 3

Active Ingredient

RISPERIDONE

Application Number

78036

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2014-03-10

Regulatory Status

Discontinued

2014
10 Mar
Discontinued Application: 78036

Drug Name

RISPERIDONE

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2014-03-10

78036 / 4

Active Ingredient

RISPERIDONE

Application Number

78036

Product Number

4

Dosage Form

-

Strength

2MG

Approval Date

2014-03-10

Regulatory Status

Discontinued

2014
10 Mar
Discontinued Application: 78036

Drug Name

RISPERIDONE

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2014-03-10

78036 / 5

Active Ingredient

RISPERIDONE

Application Number

78036

Product Number

5

Dosage Form

-

Strength

3MG

Approval Date

2014-03-10

Regulatory Status

Discontinued

2014
10 Mar
Discontinued Application: 78036

Drug Name

RISPERIDONE

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2014-03-10

78036 / 6

Active Ingredient

RISPERIDONE

Application Number

78036

Product Number

6

Dosage Form

-

Strength

4MG

Approval Date

2014-03-10

Regulatory Status

Discontinued

2013
08 Apr
Discontinued Application: 78464

Drug Name

RISPERIDONE

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2013-04-08

78464 / 1

Active Ingredient

RISPERIDONE

Application Number

78464

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2013-04-08

Regulatory Status

Discontinued

2013
08 Apr
Discontinued Application: 78464

Drug Name

RISPERIDONE

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2013-04-08

78464 / 2

Active Ingredient

RISPERIDONE

Application Number

78464

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2013-04-08

Regulatory Status

Discontinued

2013
08 Apr
Discontinued Application: 78464

Drug Name

RISPERIDONE

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2013-04-08

78464 / 3

Active Ingredient

RISPERIDONE

Application Number

78464

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2013-04-08

Regulatory Status

Discontinued

2013
08 Apr
Discontinued Application: 78464

Drug Name

RISPERIDONE

Product Number

4

Dosage Form

-

Strength

3MG

Approval Date

2013-04-08

78464 / 4

Active Ingredient

RISPERIDONE

Application Number

78464

Product Number

4

Dosage Form

-

Strength

3MG

Approval Date

2013-04-08

Regulatory Status

Discontinued

2013
08 Apr
Discontinued Application: 78464

Drug Name

RISPERIDONE

Product Number

5

Dosage Form

-

Strength

4MG

Approval Date

2013-04-08

78464 / 5

Active Ingredient

RISPERIDONE

Application Number

78464

Product Number

5

Dosage Form

-

Strength

4MG

Approval Date

2013-04-08

Regulatory Status

Discontinued

2007
22 Oct
Discontinued Application: 77131

Drug Name

RIVASTIGMINE TARTRATE

Product Number

1

Dosage Form

-

Strength

EQ 1.5MG BASE

Approval Date

2007-10-22

77131 / 1

Active Ingredient

RIVASTIGMINE TARTRATE

Application Number

77131

Product Number

1

Dosage Form

-

Strength

EQ 1.5MG BASE

Approval Date

2007-10-22

Regulatory Status

Discontinued

2007
22 Oct
Discontinued Application: 77131

Drug Name

RIVASTIGMINE TARTRATE

Product Number

2

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2007-10-22

77131 / 2

Active Ingredient

RIVASTIGMINE TARTRATE

Application Number

77131

Product Number

2

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2007-10-22

Regulatory Status

Discontinued

2007
22 Oct
Discontinued Application: 77131

Drug Name

RIVASTIGMINE TARTRATE

Product Number

3

Dosage Form

-

Strength

EQ 4.5MG BASE

Approval Date

2007-10-22

77131 / 3

Active Ingredient

RIVASTIGMINE TARTRATE

Application Number

77131

Product Number

3

Dosage Form

-

Strength

EQ 4.5MG BASE

Approval Date

2007-10-22

Regulatory Status

Discontinued

2007
22 Oct
Discontinued Application: 77131

Drug Name

RIVASTIGMINE TARTRATE

Product Number

4

Dosage Form

-

Strength

EQ 6MG BASE

Approval Date

2007-10-22

77131 / 4

Active Ingredient

RIVASTIGMINE TARTRATE

Application Number

77131

Product Number

4

Dosage Form

-

Strength

EQ 6MG BASE

Approval Date

2007-10-22

Regulatory Status

Discontinued

2016
19 Jul
Discontinued Application: 79169

Drug Name

ROSUVASTATIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2016-07-19

79169 / 1

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

79169

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2016-07-19

Regulatory Status

Discontinued

2016
19 Jul
Discontinued Application: 79169

Drug Name

ROSUVASTATIN CALCIUM

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2016-07-19

79169 / 2

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

79169

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2016-07-19

Regulatory Status

Discontinued

2016
19 Jul
Discontinued Application: 79169

Drug Name

ROSUVASTATIN CALCIUM

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2016-07-19

79169 / 3

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

79169

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2016-07-19

Regulatory Status

Discontinued

2016
19 Jul
Discontinued Application: 79169

Drug Name

ROSUVASTATIN CALCIUM

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2016-07-19

79169 / 4

Active Ingredient

ROSUVASTATIN CALCIUM

Application Number

79169

Product Number

4

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2016-07-19

Regulatory Status

Discontinued

2023
31 Jul
Discontinued Application: 206078

Drug Name

SAXAGLIPTIN

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2023-07-31

206078 / 1

Active Ingredient

SAXAGLIPTIN HYDROCHLORIDE

Application Number

206078

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2023-07-31

Regulatory Status

Discontinued

2023
31 Jul
Discontinued Application: 206078

Drug Name

SAXAGLIPTIN

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2023-07-31

206078 / 2

Active Ingredient

SAXAGLIPTIN HYDROCHLORIDE

Application Number

206078

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2023-07-31

Regulatory Status

Discontinued

2023
31 Jul
Discontinued Application: 206081

Drug Name

SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG;EQ 5MG BASE

Approval Date

2023-07-31

206081 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Application Number

206081

Product Number

1

Dosage Form

-

Strength

500MG;EQ 5MG BASE

Approval Date

2023-07-31

Regulatory Status

Discontinued

2023
31 Jul
Discontinued Application: 206081

Drug Name

SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

1GM;EQ 2.5MG BASE

Approval Date

2023-07-31

206081 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Application Number

206081

Product Number

2

Dosage Form

-

Strength

1GM;EQ 2.5MG BASE

Approval Date

2023-07-31

Regulatory Status

Discontinued

2023
31 Jul
Discontinued Application: 206081

Drug Name

SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

1GM;EQ 5MG BASE

Approval Date

2023-07-31

206081 / 3

Active Ingredient

METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE

Application Number

206081

Product Number

3

Dosage Form

-

Strength

1GM;EQ 5MG BASE

Approval Date

2023-07-31

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17322

Drug Name

SELENOMETHIONINE SE 75

Product Number

1

Dosage Form

-

Strength

500uCi/ML

Approval Date

1982-01-01

17322 / 1

Active Ingredient

SELENOMETHIONINE SE-75

Application Number

17322

Product Number

1

Dosage Form

-

Strength

500uCi/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2007
06 Feb
Discontinued Application: 77977

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2007-02-06

77977 / 1

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

77977

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2007-02-06

Regulatory Status

Discontinued

2007
06 Feb
Discontinued Application: 77977

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2007-02-06

77977 / 2

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

77977

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2007-02-06

Regulatory Status

Discontinued

2007
06 Feb
Discontinued Application: 77977

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2007-02-06

77977 / 3

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

77977

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2007-02-06

Regulatory Status

Discontinued

2007
06 Feb
Discontinued Application: 77977

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2007-02-06

77977 / 4

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

77977

Product Number

4

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2007-02-06

Regulatory Status

Discontinued

2007
06 Feb
Discontinued Application: 77977

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2007-02-06

77977 / 5

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

77977

Product Number

5

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2007-02-06

Regulatory Status

Discontinued

2007
06 Feb
Discontinued Application: 78108

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2007-02-06

78108 / 1

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

78108

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2007-02-06

Regulatory Status

Discontinued

2007
06 Feb
Discontinued Application: 78108

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2007-02-06

78108 / 2

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

78108

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2007-02-06

Regulatory Status

Discontinued

2007
06 Feb
Discontinued Application: 78108

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2007-02-06

78108 / 3

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

78108

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2007-02-06

Regulatory Status

Discontinued

2006
20 Dec
Discontinued Application: 76285

Drug Name

SIMVASTATIN

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2006-12-20

76285 / 1

Active Ingredient

SIMVASTATIN

Application Number

76285

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2006-12-20

Regulatory Status

Discontinued

2006
20 Dec
Discontinued Application: 76285

Drug Name

SIMVASTATIN

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2006-12-20

76285 / 2

Active Ingredient

SIMVASTATIN

Application Number

76285

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2006-12-20

Regulatory Status

Discontinued

2006
20 Dec
Discontinued Application: 76285

Drug Name

SIMVASTATIN

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2006-12-20

76285 / 3

Active Ingredient

SIMVASTATIN

Application Number

76285

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2006-12-20

Regulatory Status

Discontinued

2006
20 Dec
Discontinued Application: 76285

Drug Name

SIMVASTATIN

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2006-12-20

76285 / 4

Active Ingredient

SIMVASTATIN

Application Number

76285

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2006-12-20

Regulatory Status

Discontinued

2006
23 Jun
Discontinued Application: 76285

Drug Name

SIMVASTATIN

Product Number

5

Dosage Form

-

Strength

80MG

Approval Date

2006-06-23

76285 / 5

Active Ingredient

SIMVASTATIN

Application Number

76285

Product Number

5

Dosage Form

-

Strength

80MG

Approval Date

2006-06-23

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17315

Drug Name

SODIUM IODIDE I 131

Product Number

1

Dosage Form

-

Strength

50mCi/ML

Approval Date

1982-01-01

17315 / 1

Active Ingredient

SODIUM IODIDE I-131

Application Number

17315

Product Number

1

Dosage Form

-

Strength

50mCi/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2018
26 Nov
Discontinued Application: 210467

Drug Name

SODIUM NITROPRUSSIDE

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

2018-11-26

210467 / 1

Active Ingredient

SODIUM NITROPRUSSIDE

Application Number

210467

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

2018-11-26

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17321

Drug Name

SODIUM PERTECHNETATE TC 99M

Product Number

1

Dosage Form

-

Strength

12mCi/ML

Approval Date

1982-01-01

17321 / 1

Active Ingredient

TECHNETIUM TC-99M SODIUM PERTECHNETATE

Application Number

17321

Product Number

1

Dosage Form

-

Strength

12mCi/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17321

Drug Name

SODIUM PERTECHNETATE TC 99M

Product Number

2

Dosage Form

-

Strength

24mCi/ML

Approval Date

1982-01-01

17321 / 2

Active Ingredient

TECHNETIUM TC-99M SODIUM PERTECHNETATE

Application Number

17321

Product Number

2

Dosage Form

-

Strength

24mCi/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17321

Drug Name

SODIUM PERTECHNETATE TC 99M

Product Number

3

Dosage Form

-

Strength

48mCi/ML

Approval Date

1982-01-01

17321 / 3

Active Ingredient

TECHNETIUM TC-99M SODIUM PERTECHNETATE

Application Number

17321

Product Number

3

Dosage Form

-

Strength

48mCi/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2002
24 Dec
Discontinued Application: 76041

Drug Name

SOTRET

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2002-12-24

76041 / 1

Active Ingredient

ISOTRETINOIN

Application Number

76041

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2002-12-24

Regulatory Status

Discontinued

2002
24 Dec
Discontinued Application: 76041

Drug Name

SOTRET

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2002-12-24

76041 / 2

Active Ingredient

ISOTRETINOIN

Application Number

76041

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2002-12-24

Regulatory Status

Discontinued

2002
24 Dec
Discontinued Application: 76041

Drug Name

SOTRET

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2002-12-24

76041 / 3

Active Ingredient

ISOTRETINOIN

Application Number

76041

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2002-12-24

Regulatory Status

Discontinued

2003
20 Jun
Discontinued Application: 76503

Drug Name

SOTRET

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2003-06-20

76503 / 1

Active Ingredient

ISOTRETINOIN

Application Number

76503

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2003-06-20

Regulatory Status

Discontinued

2001
26 Jun
Discontinued Application: 21105

Drug Name

SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PHENAZOPYRIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

200MG,N/A,N/A;N/A,800MG,160MG

Approval Date

2001-06-26

21105 / 1

Active Ingredient

PHENAZOPYRIDINE HYDROCHLORIDE; SULFAMETHOXAZOLE; TRIMETHOPRIM

Application Number

21105

Product Number

1

Dosage Form

-

Strength

200MG,N/A,N/A;N/A,800MG,160MG

Approval Date

2001-06-26

Regulatory Status

Discontinued

2009
10 Aug
Discontinued Application: 76554

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2009-08-10

76554 / 1

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

76554

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2009-08-10

Regulatory Status

Discontinued

2009
10 Aug
Discontinued Application: 76554

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2009-08-10

76554 / 2

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

76554

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2009-08-10

Regulatory Status

Discontinued

2009
09 Feb
Discontinued Application: 76572

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2009-02-09

76572 / 1

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

76572

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2009-02-09

Regulatory Status

Discontinued

2009
10 Aug
Discontinued Application: 78295

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2009-08-10

78295 / 1

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

78295

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2009-08-10

Regulatory Status

Discontinued

2009
10 Aug
Discontinued Application: 78295

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2009-08-10

78295 / 2

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

78295

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2009-08-10

Regulatory Status

Discontinued

2009
10 Aug
Discontinued Application: 78295

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2009-08-10

78295 / 3

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

78295

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2009-08-10

Regulatory Status

Discontinued

2019
06 Feb
Discontinued Application: 202988

Drug Name

SYLEVIA

Product Number

1

Dosage Form

-

Strength

0.03MG;0.15MG

Approval Date

2019-02-06

202988 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

202988

Product Number

1

Dosage Form

-

Strength

0.03MG;0.15MG

Approval Date

2019-02-06

Regulatory Status

Discontinued

2010
15 Jul
Discontinued Application: 90931

Drug Name

TAMSULOSIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.4MG

Approval Date

2010-07-15

90931 / 1

Active Ingredient

TAMSULOSIN HYDROCHLORIDE

Application Number

90931

Product Number

1

Dosage Form

-

Strength

0.4MG

Approval Date

2010-07-15

Regulatory Status

Discontinued

2009
10 Jul
Discontinued Application: 79157

Drug Name

TECHNETIUM TC 99M SESTAMIBI

Product Number

1

Dosage Form

-

Strength

10-30mCi

Approval Date

2009-07-10

79157 / 1

Active Ingredient

TECHNETIUM TC-99M SESTAMIBI KIT

Application Number

79157

Product Number

1

Dosage Form

-

Strength

10-30mCi

Approval Date

2009-07-10

Regulatory Status

Discontinued

2013
03 Jun
Discontinued Application: 201720

Drug Name

TESTOSTERONE CYPIONATE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2013-06-03

201720 / 1

Active Ingredient

TESTOSTERONE CYPIONATE

Application Number

201720

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2013-06-03

Regulatory Status

Discontinued

2013
03 Jun
Discontinued Application: 201720

Drug Name

TESTOSTERONE CYPIONATE

Product Number

2

Dosage Form

-

Strength

200MG/ML

Approval Date

2013-06-03

201720 / 2

Active Ingredient

TESTOSTERONE CYPIONATE

Application Number

201720

Product Number

2

Dosage Form

-

Strength

200MG/ML

Approval Date

2013-06-03

Regulatory Status

Discontinued

2015
17 Aug
Discontinued Application: 206129

Drug Name

TETRABENAZINE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2015-08-17

206129 / 1

Active Ingredient

TETRABENAZINE

Application Number

206129

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2015-08-17

Regulatory Status

Discontinued

2015
17 Aug
Discontinued Application: 206129

Drug Name

TETRABENAZINE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2015-08-17

206129 / 2

Active Ingredient

TETRABENAZINE

Application Number

206129

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2015-08-17

Regulatory Status

Discontinued

2004
27 Apr
Discontinued Application: 40539

Drug Name

THEOPHYLLINE

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2004-04-27

40539 / 1

Active Ingredient

THEOPHYLLINE

Application Number

40539

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2004-04-27

Regulatory Status

Discontinued

2004
27 Apr
Discontinued Application: 40543

Drug Name

THEOPHYLLINE

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2004-04-27

40543 / 1

Active Ingredient

THEOPHYLLINE

Application Number

40543

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2004-04-27

Regulatory Status

Discontinued

2004
30 Apr
Discontinued Application: 40546

Drug Name

THEOPHYLLINE

Product Number

1

Dosage Form

-

Strength

450MG

Approval Date

2004-04-30

40546 / 1

Active Ingredient

THEOPHYLLINE

Application Number

40546

Product Number

1

Dosage Form

-

Strength

450MG

Approval Date

2004-04-30

Regulatory Status

Discontinued

2004
30 Apr
Discontinued Application: 40548

Drug Name

THEOPHYLLINE

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2004-04-30

40548 / 1

Active Ingredient

THEOPHYLLINE

Application Number

40548

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2004-04-30

Regulatory Status

Discontinued

2011
04 Nov
Discontinued Application: 77555

Drug Name

TIAGABINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2011-11-04

77555 / 1

Active Ingredient

TIAGABINE HYDROCHLORIDE

Application Number

77555

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2011-11-04

Regulatory Status

Discontinued

2011
04 Nov
Discontinued Application: 77555

Drug Name

TIAGABINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2011-11-04

77555 / 2

Active Ingredient

TIAGABINE HYDROCHLORIDE

Application Number

77555

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2011-11-04

Regulatory Status

Discontinued

2002
26 Sep
Discontinued Application: 75526

Drug Name

TICLOPIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2002-09-26

75526 / 1

Active Ingredient

TICLOPIDINE HYDROCHLORIDE

Application Number

75526

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2002-09-26

Regulatory Status

Discontinued

2009
27 Mar
Discontinued Application: 76327

Drug Name

TOPIRAMATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-03-27

76327 / 1

Active Ingredient

TOPIRAMATE

Application Number

76327

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-03-27

Regulatory Status

Discontinued

2009
27 Mar
Discontinued Application: 76327

Drug Name

TOPIRAMATE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2009-03-27

76327 / 2

Active Ingredient

TOPIRAMATE

Application Number

76327

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2009-03-27

Regulatory Status

Discontinued

2009
27 Mar
Discontinued Application: 76327

Drug Name

TOPIRAMATE

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2009-03-27

76327 / 3

Active Ingredient

TOPIRAMATE

Application Number

76327

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2009-03-27

Regulatory Status

Discontinued

2009
27 Mar
Discontinued Application: 90278

Drug Name

TOPIRAMATE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2009-03-27

90278 / 4

Active Ingredient

TOPIRAMATE

Application Number

90278

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2009-03-27

Regulatory Status

Discontinued

2013
29 Aug
Discontinued Application: 202203

Drug Name

TOPOTECAN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/VIAL

Approval Date

2013-08-29

202203 / 1

Active Ingredient

TOPOTECAN HYDROCHLORIDE

Application Number

202203

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/VIAL

Approval Date

2013-08-29

Regulatory Status

Discontinued

2008
26 Feb
Discontinued Application: 78478

Drug Name

TORSEMIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2008-02-26

78478 / 1

Active Ingredient

TORSEMIDE

Application Number

78478

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2008-02-26

Regulatory Status

Discontinued

2008
26 Feb
Discontinued Application: 78478

Drug Name

TORSEMIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2008-02-26

78478 / 2

Active Ingredient

TORSEMIDE

Application Number

78478

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2008-02-26

Regulatory Status

Discontinued

2008
26 Feb
Discontinued Application: 78478

Drug Name

TORSEMIDE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2008-02-26

78478 / 3

Active Ingredient

TORSEMIDE

Application Number

78478

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2008-02-26

Regulatory Status

Discontinued

2008
26 Feb
Discontinued Application: 78478

Drug Name

TORSEMIDE

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2008-02-26

78478 / 4

Active Ingredient

TORSEMIDE

Application Number

78478

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2008-02-26

Regulatory Status

Discontinued

2011
30 Dec
Discontinued Application: 91607

Drug Name

TRAMADOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2011-12-30

91607 / 1

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

91607

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2011-12-30

Regulatory Status

Discontinued

2011
30 Dec
Discontinued Application: 91607

Drug Name

TRAMADOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2011-12-30

91607 / 2

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

91607

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2011-12-30

Regulatory Status

Discontinued

2011
30 Dec
Discontinued Application: 91607

Drug Name

TRAMADOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2011-12-30

91607 / 3

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

91607

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2011-12-30

Regulatory Status

Discontinued

2011
07 Dec
Discontinued Application: 201384

Drug Name

TRAMADOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2011-12-07

201384 / 1

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

201384

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2011-12-07

Regulatory Status

Discontinued

2011
07 Dec
Discontinued Application: 201384

Drug Name

TRAMADOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2011-12-07

201384 / 2

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

201384

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2011-12-07

Regulatory Status

Discontinued

2011
07 Dec
Discontinued Application: 201384

Drug Name

TRAMADOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2011-12-07

201384 / 3

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

201384

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2011-12-07

Regulatory Status

Discontinued

2005
16 Dec
Discontinued Application: 77184

Drug Name

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;37.5MG

Approval Date

2005-12-16

77184 / 1

Active Ingredient

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Application Number

77184

Product Number

1

Dosage Form

-

Strength

325MG;37.5MG

Approval Date

2005-12-16

Regulatory Status

Discontinued

1990
27 Dec
Discontinued Application: 19967

Drug Name

ULTRAVATE

Product Number

1

Dosage Form

-

Strength

0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1990-12-27

19967 / 1

Active Ingredient

HALOBETASOL PROPIONATE

Application Number

19967

Product Number

1

Dosage Form

-

Strength

0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1990-12-27

Regulatory Status

Discontinued

1990
17 Dec
Discontinued Application: 19968

Drug Name

ULTRAVATE

Product Number

1

Dosage Form

-

Strength

0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1990-12-17

19968 / 1

Active Ingredient

HALOBETASOL PROPIONATE

Application Number

19968

Product Number

1

Dosage Form

-

Strength

0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1990-12-17

Regulatory Status

Discontinued

2013
22 Feb
Discontinued Application: 91037

Drug Name

VALPROIC ACID

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2013-02-22

91037 / 1

Active Ingredient

VALPROIC ACID

Application Number

91037

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2013-02-22

Regulatory Status

Discontinued

2009
17 Jun
Discontinued Application: 79001

Drug Name

VECURONIUM BROMIDE

Product Number

2

Dosage Form

-

Strength

20MG/VIAL

Approval Date

2009-06-17

79001 / 2

Active Ingredient

VECURONIUM BROMIDE

Application Number

79001

Product Number

2

Dosage Form

-

Strength

20MG/VIAL

Approval Date

2009-06-17

Regulatory Status

Discontinued

2010
18 Aug
Discontinued Application: 91272

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2010-08-18

91272 / 1

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

91272

Product Number

1

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2010-08-18

Regulatory Status

Discontinued

2010
18 Aug
Discontinued Application: 91272

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2010-08-18

91272 / 2

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

91272

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2010-08-18

Regulatory Status

Discontinued

2010
18 Aug
Discontinued Application: 91272

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2010-08-18

91272 / 3

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

91272

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2010-08-18

Regulatory Status

Discontinued

2019
08 Jan
Discontinued Application: 91272

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 225MG BASE

Approval Date

2019-01-08

91272 / 4

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

91272

Product Number

4

Dosage Form

-

Strength

EQ 225MG BASE

Approval Date

2019-01-08

Regulatory Status

Discontinued

2011
30 Dec
Discontinued Application: 90529

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2011-12-30

90529 / 1

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

90529

Product Number

1

Dosage Form

-

Strength

120MG

Approval Date

2011-12-30

Regulatory Status

Discontinued

2011
30 Dec
Discontinued Application: 90529

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2011-12-30

90529 / 2

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

90529

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2011-12-30

Regulatory Status

Discontinued

2011
30 Dec
Discontinued Application: 90529

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

240MG

Approval Date

2011-12-30

90529 / 3

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

90529

Product Number

3

Dosage Form

-

Strength

240MG

Approval Date

2011-12-30

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17950

Drug Name

WESTCORT

Product Number

1

Dosage Form

-

Strength

0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17950 / 1

Active Ingredient

HYDROCORTISONE VALERATE

Application Number

17950

Product Number

1

Dosage Form

-

Strength

0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1983
08 Aug
Discontinued Application: 18726

Drug Name

WESTCORT

Product Number

1

Dosage Form

-

Strength

0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1983-08-08

18726 / 1

Active Ingredient

HYDROCORTISONE VALERATE

Application Number

18726

Product Number

1

Dosage Form

-

Strength

0.2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1983-08-08

Regulatory Status

Discontinued

2018
12 Sep
Discontinued Application: 206185

Drug Name

XELPROS

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

2018-09-12

206185 / 1

Active Ingredient

LATANOPROST

Application Number

206185

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

2018-09-12

Regulatory Status

Discontinued

2013
04 Mar
Discontinued Application: 90018

Drug Name

ZOLEDRONIC ACID

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/VIAL

Approval Date

2013-03-04

90018 / 1

Active Ingredient

ZOLEDRONIC ACID

Application Number

90018

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/VIAL

Approval Date

2013-03-04

Regulatory Status

Discontinued

2013
04 Mar
Discontinued Application: 202746

Drug Name

ZOLEDRONIC ACID

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/5ML

Approval Date

2013-03-04

202746 / 1

Active Ingredient

ZOLEDRONIC ACID

Application Number

202746

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/5ML

Approval Date

2013-03-04

Regulatory Status

Discontinued

2014
13 Nov
Discontinued Application: 203476

Drug Name

ZOLMITRIPTAN

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2014-11-13

203476 / 1

Active Ingredient

ZOLMITRIPTAN

Application Number

203476

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2014-11-13

Regulatory Status

Discontinued

2014
13 Nov
Discontinued Application: 203476

Drug Name

ZOLMITRIPTAN

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2014-11-13

203476 / 2

Active Ingredient

ZOLMITRIPTAN

Application Number

203476

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2014-11-13

Regulatory Status

Discontinued

2007
23 Apr
Discontinued Application: 77359

Drug Name

ZOLPIDEM TARTRATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-04-23

77359 / 1

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

77359

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-04-23

Regulatory Status

Discontinued

2007
23 Apr
Discontinued Application: 77359

Drug Name

ZOLPIDEM TARTRATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-04-23

77359 / 2

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

77359

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-04-23

Regulatory Status

Discontinued

2007
23 Apr
Discontinued Application: 78055

Drug Name

ZOLPIDEM TARTRATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-04-23

78055 / 1

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

78055

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2007-04-23

Regulatory Status

Discontinued

2007
23 Apr
Discontinued Application: 78055

Drug Name

ZOLPIDEM TARTRATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-04-23

78055 / 2

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

78055

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2007-04-23

Regulatory Status

Discontinued

2006
17 Mar
Discontinued Application: 77634

Drug Name

ZONISAMIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2006-03-17

77634 / 1

Active Ingredient

ZONISAMIDE

Application Number

77634

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2006-03-17

Regulatory Status

Discontinued

2006
17 Mar
Discontinued Application: 77634

Drug Name

ZONISAMIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2006-03-17

77634 / 2

Active Ingredient

ZONISAMIDE

Application Number

77634

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2006-03-17

Regulatory Status

Discontinued

2006
17 Mar
Discontinued Application: 77634

Drug Name

ZONISAMIDE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2006-03-17

77634 / 3

Active Ingredient

ZONISAMIDE

Application Number

77634

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2006-03-17

Regulatory Status

Discontinued

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Drug Status Breakdown
698 total
  • Discontinued
Official Source

FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.

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FDA Approved Drug Record Details Preview

Explore important FDA approved drug information available in the records above.

Drug Name

ABSORICA LD

Application Number

211913

Product Number

3

Active Ingredient

ISOTRETINOIN

Dosage Form

-

Strength

20MG

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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