Sun Pharmaceutical Industries Limited RX
FDA Approved Drugs

Sun Pharmaceutical Industries Limited RX

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.

RX
  • Total Records 271
  • Latest Approval Date Jul 28, 2026
  • 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 RX

Country

India

Website

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Company Snapshot

Sun Pharmaceutical Industries Limited RX

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

India

sunpharma.com/ View on Map
FDA Approved Drug Records ( 271 records )
2012
25 May
RX Application: 21951

Drug Name

ABSORICA

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2012-05-25

21951 / 1

Active Ingredient

ISOTRETINOIN

Application Number

21951

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2012-05-25

Regulatory Status

RX

2012
25 May
RX Application: 21951

Drug Name

ABSORICA

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2012-05-25

21951 / 2

Active Ingredient

ISOTRETINOIN

Application Number

21951

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2012-05-25

Regulatory Status

RX

2012
25 May
RX Application: 21951

Drug Name

ABSORICA

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2012-05-25

21951 / 3

Active Ingredient

ISOTRETINOIN

Application Number

21951

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2012-05-25

Regulatory Status

RX

2012
25 May
RX Application: 21951

Drug Name

ABSORICA

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2012-05-25

21951 / 4

Active Ingredient

ISOTRETINOIN

Application Number

21951

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2012-05-25

Regulatory Status

RX

2014
15 Aug
RX Application: 21951

Drug Name

ABSORICA

Product Number

5

Dosage Form

-

Strength

25MG

Approval Date

2014-08-15

21951 / 5

Active Ingredient

ISOTRETINOIN

Application Number

21951

Product Number

5

Dosage Form

-

Strength

25MG

Approval Date

2014-08-15

Regulatory Status

RX

2014
15 Aug
RX Application: 21951

Drug Name

ABSORICA

Product Number

6

Dosage Form

-

Strength

35MG

Approval Date

2014-08-15

21951 / 6

Active Ingredient

ISOTRETINOIN

Application Number

21951

Product Number

6

Dosage Form

-

Strength

35MG

Approval Date

2014-08-15

Regulatory Status

RX

2019
05 Nov
RX Application: 211913

Drug Name

ABSORICA LD

Product Number

1

Dosage Form

-

Strength

8MG

Approval Date

2019-11-05

211913 / 1

Active Ingredient

ISOTRETINOIN

Application Number

211913

Product Number

1

Dosage Form

-

Strength

8MG

Approval Date

2019-11-05

Regulatory Status

RX

2019
05 Nov
RX Application: 211913

Drug Name

ABSORICA LD

Product Number

2

Dosage Form

-

Strength

16MG

Approval Date

2019-11-05

211913 / 2

Active Ingredient

ISOTRETINOIN

Application Number

211913

Product Number

2

Dosage Form

-

Strength

16MG

Approval Date

2019-11-05

Regulatory Status

RX

2019
05 Nov
RX Application: 211913

Drug Name

ABSORICA LD

Product Number

4

Dosage Form

-

Strength

24MG

Approval Date

2019-11-05

211913 / 4

Active Ingredient

ISOTRETINOIN

Application Number

211913

Product Number

4

Dosage Form

-

Strength

24MG

Approval Date

2019-11-05

Regulatory Status

RX

2019
05 Nov
RX Application: 211913

Drug Name

ABSORICA LD

Product Number

6

Dosage Form

-

Strength

32MG

Approval Date

2019-11-05

211913 / 6

Active Ingredient

ISOTRETINOIN

Application Number

211913

Product Number

6

Dosage Form

-

Strength

32MG

Approval Date

2019-11-05

Regulatory Status

RX

1982
01 Jan
RX Application: 87083

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

1982-01-01

87083 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

87083

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

1982-01-01

Regulatory Status

RX

2017
21 Jul
RX Application: 207857

Drug Name

ALBUTEROL SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 0.083% BASE

Approval Date

2017-07-21

207857 / 1

Active Ingredient

ALBUTEROL SULFATE

Application Number

207857

Product Number

1

Dosage Form

-

Strength

EQ 0.083% BASE

Approval Date

2017-07-21

Regulatory Status

RX

2017
07 Aug
RX Application: 207875

Drug Name

ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.083% BASE;0.017%

Approval Date

2017-08-07

207875 / 1

Active Ingredient

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Application Number

207875

Product Number

1

Dosage Form

-

Strength

EQ 0.083% BASE;0.017%

Approval Date

2017-08-07

Regulatory Status

RX

2008
10 Sep
RX Application: 90022

Drug Name

ALENDRONATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2008-09-10

90022 / 1

Active Ingredient

ALENDRONATE SODIUM

Application Number

90022

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2008-09-10

Regulatory Status

RX

2008
10 Sep
RX Application: 90022

Drug Name

ALENDRONATE SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2008-09-10

90022 / 2

Active Ingredient

ALENDRONATE SODIUM

Application Number

90022

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2008-09-10

Regulatory Status

RX

2008
10 Sep
RX Application: 90022

Drug Name

ALENDRONATE SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 35MG BASE

Approval Date

2008-09-10

90022 / 3

Active Ingredient

ALENDRONATE SODIUM

Application Number

90022

Product Number

3

Dosage Form

-

Strength

EQ 35MG BASE

Approval Date

2008-09-10

Regulatory Status

RX

2008
10 Sep
RX Application: 90022

Drug Name

ALENDRONATE SODIUM

Product Number

4

Dosage Form

-

Strength

EQ 70MG BASE

Approval Date

2008-09-10

90022 / 4

Active Ingredient

ALENDRONATE SODIUM

Application Number

90022

Product Number

4

Dosage Form

-

Strength

EQ 70MG BASE

Approval Date

2008-09-10

Regulatory Status

RX

1987
14 Jul
RX Application: 89399

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1987-07-14

89399 / 1

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

89399

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1987-07-14

Regulatory Status

RX

1987
14 Jul
RX Application: 89399

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1987-07-14

89399 / 2

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

89399

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1987-07-14

Regulatory Status

RX

1987
14 Jul
RX Application: 89399

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1987-07-14

89399 / 3

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

89399

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1987-07-14

Regulatory Status

RX

1987
14 Jul
RX Application: 89399

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

75MG

Approval Date

1987-07-14

89399 / 4

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

89399

Product Number

4

Dosage Form

-

Strength

75MG

Approval Date

1987-07-14

Regulatory Status

RX

1987
14 Jul
RX Application: 89399

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

100MG

Approval Date

1987-07-14

89399 / 5

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

89399

Product Number

5

Dosage Form

-

Strength

100MG

Approval Date

1987-07-14

Regulatory Status

RX

1987
14 Jul
RX Application: 89399

Drug Name

AMITRIPTYLINE HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

150MG

Approval Date

1987-07-14

89399 / 6

Active Ingredient

AMITRIPTYLINE HYDROCHLORIDE

Application Number

89399

Product Number

6

Dosage Form

-

Strength

150MG

Approval Date

1987-07-14

Regulatory Status

RX

1982
01 Jan
RX Application: 17858

Drug Name

AN-SULFUR COLLOID

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

1982-01-01

17858 / 1

Active Ingredient

TECHNETIUM TC-99M SULFUR COLLOID KIT

Application Number

17858

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

1982-01-01

Regulatory Status

RX

2022
26 May
RX Application: 215385

Drug Name

ARFORMOTEROL TARTRATE

Product Number

1

Dosage Form

-

Strength

EQ 0.015MG BASE/2ML

Approval Date

2022-05-26

215385 / 1

Active Ingredient

ARFORMOTEROL TARTRATE

Application Number

215385

Product Number

1

Dosage Form

-

Strength

EQ 0.015MG BASE/2ML

Approval Date

2022-05-26

Regulatory Status

RX

2004
11 Feb
RX Application: 76344

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2004-02-11

76344 / 1

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

76344

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2004-02-11

Regulatory Status

RX

2004
11 Feb
RX Application: 76344

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2004-02-11

76344 / 2

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

76344

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2004-02-11

Regulatory Status

RX

2004
11 Feb
RX Application: 76344

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2004-02-11

76344 / 3

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

76344

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2004-02-11

Regulatory Status

RX

2004
11 Feb
RX Application: 76344

Drug Name

BENAZEPRIL HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2004-02-11

76344 / 4

Active Ingredient

BENAZEPRIL HYDROCHLORIDE

Application Number

76344

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2004-02-11

Regulatory Status

RX

2009
06 Jul
RX Application: 79110

Drug Name

BICALUTAMIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2009-07-06

79110 / 1

Active Ingredient

BICALUTAMIDE

Application Number

79110

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2009-07-06

Regulatory Status

RX

2019
26 Apr
RX Application: 209324

Drug Name

BOSENTAN

Product Number

1

Dosage Form

-

Strength

62.5MG

Approval Date

2019-04-26

209324 / 1

Active Ingredient

BOSENTAN

Application Number

209324

Product Number

1

Dosage Form

-

Strength

62.5MG

Approval Date

2019-04-26

Regulatory Status

RX

2019
26 Apr
RX Application: 209324

Drug Name

BOSENTAN

Product Number

2

Dosage Form

-

Strength

125MG

Approval Date

2019-04-26

209324 / 2

Active Ingredient

BOSENTAN

Application Number

209324

Product Number

2

Dosage Form

-

Strength

125MG

Approval Date

2019-04-26

Regulatory Status

RX

2016
08 Apr
RX Application: 206911

Drug Name

BROMSITE

Product Number

1

Dosage Form

-

Strength

EQ 0.075% ACID

Approval Date

2016-04-08

206911 / 1

Active Ingredient

BROMFENAC SODIUM

Application Number

206911

Product Number

1

Dosage Form

-

Strength

EQ 0.075% ACID

Approval Date

2016-04-08

Regulatory Status

RX

2021
14 Apr
RX Application: 211922

Drug Name

BUDESONIDE

Product Number

1

Dosage Form

-

Strength

0.25MG/2ML

Approval Date

2021-04-14

211922 / 1

Active Ingredient

BUDESONIDE

Application Number

211922

Product Number

1

Dosage Form

-

Strength

0.25MG/2ML

Approval Date

2021-04-14

Regulatory Status

RX

2021
14 Apr
RX Application: 211922

Drug Name

BUDESONIDE

Product Number

2

Dosage Form

-

Strength

0.5MG/2ML

Approval Date

2021-04-14

211922 / 2

Active Ingredient

BUDESONIDE

Application Number

211922

Product Number

2

Dosage Form

-

Strength

0.5MG/2ML

Approval Date

2021-04-14

Regulatory Status

RX

2021
14 Apr
RX Application: 211922

Drug Name

BUDESONIDE

Product Number

3

Dosage Form

-

Strength

1MG/2ML

Approval Date

2021-04-14

211922 / 3

Active Ingredient

BUDESONIDE

Application Number

211922

Product Number

3

Dosage Form

-

Strength

1MG/2ML

Approval Date

2021-04-14

Regulatory Status

RX

2016
29 Jan
RX Application: 201760

Drug Name

BUPRENORPHINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2016-01-29

201760 / 1

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE

Application Number

201760

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2016-01-29

Regulatory Status

RX

2016
29 Jan
RX Application: 201760

Drug Name

BUPRENORPHINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2016-01-29

201760 / 2

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE

Application Number

201760

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2016-01-29

Regulatory Status

RX

2016
05 Aug
RX Application: 201633

Drug Name

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE;EQ 0.5MG BASE

Approval Date

2016-08-05

201633 / 1

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Application Number

201633

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE;EQ 0.5MG BASE

Approval Date

2016-08-05

Regulatory Status

RX

2016
05 Aug
RX Application: 201633

Drug Name

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE;EQ 2MG BASE

Approval Date

2016-08-05

201633 / 2

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Application Number

201633

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE;EQ 2MG BASE

Approval Date

2016-08-05

Regulatory Status

RX

2024
27 Sep
RX Application: 213224

Drug Name

BYNFEZIA PEN

Product Number

1

Dosage Form

-

Strength

EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)

Approval Date

2024-09-27

213224 / 1

Active Ingredient

OCTREOTIDE ACETATE

Application Number

213224

Product Number

1

Dosage Form

-

Strength

EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML)

Approval Date

2024-09-27

Regulatory Status

RX

2008
28 Oct
RX Application: 78536

Drug Name

CARBIDOPA AND LEVODOPA

Product Number

1

Dosage Form

-

Strength

10MG;100MG

Approval Date

2008-10-28

78536 / 1

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

78536

Product Number

1

Dosage Form

-

Strength

10MG;100MG

Approval Date

2008-10-28

Regulatory Status

RX

2008
28 Oct
RX Application: 78536

Drug Name

CARBIDOPA AND LEVODOPA

Product Number

2

Dosage Form

-

Strength

25MG;100MG

Approval Date

2008-10-28

78536 / 2

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

78536

Product Number

2

Dosage Form

-

Strength

25MG;100MG

Approval Date

2008-10-28

Regulatory Status

RX

2008
28 Oct
RX Application: 78536

Drug Name

CARBIDOPA AND LEVODOPA

Product Number

3

Dosage Form

-

Strength

25MG;250MG

Approval Date

2008-10-28

78536 / 3

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

78536

Product Number

3

Dosage Form

-

Strength

25MG;250MG

Approval Date

2008-10-28

Regulatory Status

RX

2009
31 Jul
RX Application: 78690

Drug Name

CARBIDOPA AND LEVODOPA

Product Number

1

Dosage Form

-

Strength

10MG;100MG

Approval Date

2009-07-31

78690 / 1

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

78690

Product Number

1

Dosage Form

-

Strength

10MG;100MG

Approval Date

2009-07-31

Regulatory Status

RX

2009
31 Jul
RX Application: 78690

Drug Name

CARBIDOPA AND LEVODOPA

Product Number

2

Dosage Form

-

Strength

25MG;100MG

Approval Date

2009-07-31

78690 / 2

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

78690

Product Number

2

Dosage Form

-

Strength

25MG;100MG

Approval Date

2009-07-31

Regulatory Status

RX

2009
31 Jul
RX Application: 78690

Drug Name

CARBIDOPA AND LEVODOPA

Product Number

3

Dosage Form

-

Strength

25MG;250MG

Approval Date

2009-07-31

78690 / 3

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

78690

Product Number

3

Dosage Form

-

Strength

25MG;250MG

Approval Date

2009-07-31

Regulatory Status

RX

2008
19 Sep
RX Application: 77926

Drug Name

CARBOPLATIN

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2008-09-19

77926 / 1

Active Ingredient

CARBOPLATIN

Application Number

77926

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2008-09-19

Regulatory Status

RX

2008
19 Sep
RX Application: 77926

Drug Name

CARBOPLATIN

Product Number

2

Dosage Form

-

Strength

150MG/15ML (10MG/ML)

Approval Date

2008-09-19

77926 / 2

Active Ingredient

CARBOPLATIN

Application Number

77926

Product Number

2

Dosage Form

-

Strength

150MG/15ML (10MG/ML)

Approval Date

2008-09-19

Regulatory Status

RX

2008
19 Sep
RX Application: 77926

Drug Name

CARBOPLATIN

Product Number

3

Dosage Form

-

Strength

450MG/45ML (10MG/ML)

Approval Date

2008-09-19

77926 / 3

Active Ingredient

CARBOPLATIN

Application Number

77926

Product Number

3

Dosage Form

-

Strength

450MG/45ML (10MG/ML)

Approval Date

2008-09-19

Regulatory Status

RX

2018
14 Aug
RX Application: 210913

Drug Name

CEQUA

Product Number

1

Dosage Form

-

Strength

0.09%

Approval Date

2018-08-14

210913 / 1

Active Ingredient

CYCLOSPORINE

Application Number

210913

Product Number

1

Dosage Form

-

Strength

0.09%

Approval Date

2018-08-14

Regulatory Status

RX

2011
26 Jul
RX Application: 91546

Drug Name

CHLOROTHIAZIDE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2011-07-26

91546 / 1

Active Ingredient

CHLOROTHIAZIDE SODIUM

Application Number

91546

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2011-07-26

Regulatory Status

RX

2022
30 Aug
RX Application: 210470

Drug Name

CIPROFLOXACIN AND DEXAMETHASONE

Product Number

1

Dosage Form

-

Strength

0.3%;0.1%

Approval Date

2022-08-30

210470 / 1

Active Ingredient

CIPROFLOXACIN; DEXAMETHASONE

Application Number

210470

Product Number

1

Dosage Form

-

Strength

0.3%;0.1%

Approval Date

2022-08-30

Regulatory Status

RX

1982
01 Jan
RX Application: 18124

Drug Name

CIS-MDP

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

1982-01-01

18124 / 1

Active Ingredient

TECHNETIUM TC-99M MEDRONATE KIT

Application Number

18124

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

1982-01-01

Regulatory Status

RX

1987
30 Jun
RX Application: 19039

Drug Name

CIS-PYRO

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

1987-06-30

19039 / 1

Active Ingredient

TECHNETIUM TC-99M PYROPHOSPHATE KIT

Application Number

19039

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

1987-06-30

Regulatory Status

RX

2001
02 Feb
RX Application: 65061

Drug Name

CLINDAMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2001-02-02

65061 / 1

Active Ingredient

CLINDAMYCIN HYDROCHLORIDE

Application Number

65061

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2001-02-02

Regulatory Status

RX

2001
02 Feb
RX Application: 65061

Drug Name

CLINDAMYCIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2001-02-02

65061 / 2

Active Ingredient

CLINDAMYCIN HYDROCHLORIDE

Application Number

65061

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2001-02-02

Regulatory Status

RX

2026
06 Apr
RX Application: 211491

Drug Name

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG;1GM

Approval Date

2026-04-06

211491 / 1

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

211491

Product Number

1

Dosage Form

-

Strength

5MG;1GM

Approval Date

2026-04-06

Regulatory Status

RX

2026
06 Apr
RX Application: 211491

Drug Name

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG;500MG

Approval Date

2026-04-06

211491 / 2

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

211491

Product Number

2

Dosage Form

-

Strength

10MG;500MG

Approval Date

2026-04-06

Regulatory Status

RX

2026
06 Apr
RX Application: 211491

Drug Name

DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

10MG;1GM

Approval Date

2026-04-06

211491 / 3

Active Ingredient

DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

211491

Product Number

3

Dosage Form

-

Strength

10MG;1GM

Approval Date

2026-04-06

Regulatory Status

RX

2019
20 Nov
RX Application: 209782

Drug Name

DEFERASIROX

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2019-11-20

209782 / 1

Active Ingredient

DEFERASIROX

Application Number

209782

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2019-11-20

Regulatory Status

RX

2019
20 Nov
RX Application: 209782

Drug Name

DEFERASIROX

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2019-11-20

209782 / 2

Active Ingredient

DEFERASIROX

Application Number

209782

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2019-11-20

Regulatory Status

RX

2019
20 Nov
RX Application: 209782

Drug Name

DEFERASIROX

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2019-11-20

209782 / 3

Active Ingredient

DEFERASIROX

Application Number

209782

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2019-11-20

Regulatory Status

RX

2025
18 Mar
RX Application: 217741

Drug Name

DEFLAZACORT

Product Number

1

Dosage Form

-

Strength

6MG

Approval Date

2025-03-18

217741 / 1

Active Ingredient

DEFLAZACORT

Application Number

217741

Product Number

1

Dosage Form

-

Strength

6MG

Approval Date

2025-03-18

Regulatory Status

RX

2025
18 Mar
RX Application: 217741

Drug Name

DEFLAZACORT

Product Number

2

Dosage Form

-

Strength

18MG

Approval Date

2025-03-18

217741 / 2

Active Ingredient

DEFLAZACORT

Application Number

217741

Product Number

2

Dosage Form

-

Strength

18MG

Approval Date

2025-03-18

Regulatory Status

RX

2025
18 Mar
RX Application: 217741

Drug Name

DEFLAZACORT

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2025-03-18

217741 / 3

Active Ingredient

DEFLAZACORT

Application Number

217741

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2025-03-18

Regulatory Status

RX

2025
18 Mar
RX Application: 217741

Drug Name

DEFLAZACORT

Product Number

4

Dosage Form

-

Strength

36MG

Approval Date

2025-03-18

217741 / 4

Active Ingredient

DEFLAZACORT

Application Number

217741

Product Number

4

Dosage Form

-

Strength

36MG

Approval Date

2025-03-18

Regulatory Status

RX

2026
27 Jan
RX Application: 219930

Drug Name

DEFLAZACORT

Product Number

1

Dosage Form

-

Strength

22.75MG/ML

Approval Date

2026-01-27

219930 / 1

Active Ingredient

DEFLAZACORT

Application Number

219930

Product Number

1

Dosage Form

-

Strength

22.75MG/ML

Approval Date

2026-01-27

Regulatory Status

RX

2023
27 Sep
RX Application: 215997

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

1

Dosage Form

-

Strength

3.125MG;3.125MG;3.125MG;3.125MG

Approval Date

2023-09-27

215997 / 1

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

215997

Product Number

1

Dosage Form

-

Strength

3.125MG;3.125MG;3.125MG;3.125MG

Approval Date

2023-09-27

Regulatory Status

RX

2023
27 Sep
RX Application: 215997

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

2

Dosage Form

-

Strength

6.25MG;6.25MG;6.25MG;6.25MG

Approval Date

2023-09-27

215997 / 2

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

215997

Product Number

2

Dosage Form

-

Strength

6.25MG;6.25MG;6.25MG;6.25MG

Approval Date

2023-09-27

Regulatory Status

RX

2023
27 Sep
RX Application: 215997

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

3

Dosage Form

-

Strength

9.375MG;9.375MG;9.375MG;9.375MG

Approval Date

2023-09-27

215997 / 3

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

215997

Product Number

3

Dosage Form

-

Strength

9.375MG;9.375MG;9.375MG;9.375MG

Approval Date

2023-09-27

Regulatory Status

RX

2023
27 Sep
RX Application: 215997

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

4

Dosage Form

-

Strength

12.5MG;12.5MG;12.5MG;12.5MG

Approval Date

2023-09-27

215997 / 4

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

215997

Product Number

4

Dosage Form

-

Strength

12.5MG;12.5MG;12.5MG;12.5MG

Approval Date

2023-09-27

Regulatory Status

RX

2026
03 Jun
RX Application: 204196

Drug Name

DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE

Product Number

1

Dosage Form

-

Strength

20MG;10MG

Approval Date

2026-06-03

204196 / 1

Active Ingredient

DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE

Application Number

204196

Product Number

1

Dosage Form

-

Strength

20MG;10MG

Approval Date

2026-06-03

Regulatory Status

RX

2017
08 Jun
RX Application: 203023

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

360MG

Approval Date

2017-06-08

203023 / 5

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

203023

Product Number

5

Dosage Form

-

Strength

360MG

Approval Date

2017-06-08

Regulatory Status

RX

2008
29 Jul
RX Application: 78597

Drug Name

DIVALPROEX SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 125MG VALPROIC ACID

Approval Date

2008-07-29

78597 / 1

Active Ingredient

DIVALPROEX SODIUM

Application Number

78597

Product Number

1

Dosage Form

-

Strength

EQ 125MG VALPROIC ACID

Approval Date

2008-07-29

Regulatory Status

RX

2008
29 Jul
RX Application: 78597

Drug Name

DIVALPROEX SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 250MG VALPROIC ACID

Approval Date

2008-07-29

78597 / 2

Active Ingredient

DIVALPROEX SODIUM

Application Number

78597

Product Number

2

Dosage Form

-

Strength

EQ 250MG VALPROIC ACID

Approval Date

2008-07-29

Regulatory Status

RX

2008
29 Jul
RX Application: 78597

Drug Name

DIVALPROEX SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 500MG VALPROIC ACID

Approval Date

2008-07-29

78597 / 3

Active Ingredient

DIVALPROEX SODIUM

Application Number

78597

Product Number

3

Dosage Form

-

Strength

EQ 500MG VALPROIC ACID

Approval Date

2008-07-29

Regulatory Status

RX

2018
09 Oct
RX Application: 210466

Drug Name

DOFETILIDE

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2018-10-09

210466 / 1

Active Ingredient

DOFETILIDE

Application Number

210466

Product Number

1

Dosage Form

-

Strength

0.125MG

Approval Date

2018-10-09

Regulatory Status

RX

2018
09 Oct
RX Application: 210466

Drug Name

DOFETILIDE

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2018-10-09

210466 / 2

Active Ingredient

DOFETILIDE

Application Number

210466

Product Number

2

Dosage Form

-

Strength

0.25MG

Approval Date

2018-10-09

Regulatory Status

RX

2018
09 Oct
RX Application: 210466

Drug Name

DOFETILIDE

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

2018-10-09

210466 / 3

Active Ingredient

DOFETILIDE

Application Number

210466

Product Number

3

Dosage Form

-

Strength

0.5MG

Approval Date

2018-10-09

Regulatory Status

RX

2012
15 Feb
RX Application: 91418

Drug Name

DOXORUBICIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2012-02-15

91418 / 1

Active Ingredient

DOXORUBICIN HYDROCHLORIDE

Application Number

91418

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2012-02-15

Regulatory Status

RX

2013
04 Feb
RX Application: 203263

Drug Name

DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

Product Number

1

Dosage Form

-

Strength

20MG/10ML (2MG/ML)

Approval Date

2013-02-04

203263 / 1

Active Ingredient

DOXORUBICIN HYDROCHLORIDE

Application Number

203263

Product Number

1

Dosage Form

-

Strength

20MG/10ML (2MG/ML)

Approval Date

2013-02-04

Regulatory Status

RX

2013
04 Feb
RX Application: 203263

Drug Name

DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)

Product Number

2

Dosage Form

-

Strength

50MG/25ML (2MG/ML)

Approval Date

2013-02-04

203263 / 2

Active Ingredient

DOXORUBICIN HYDROCHLORIDE

Application Number

203263

Product Number

2

Dosage Form

-

Strength

50MG/25ML (2MG/ML)

Approval Date

2013-02-04

Regulatory Status

RX

2000
22 Nov
RX Application: 65053

Drug Name

DOXYCYCLINE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2000-11-22

65053 / 1

Active Ingredient

DOXYCYCLINE

Application Number

65053

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2000-11-22

Regulatory Status

RX

2000
22 Nov
RX Application: 65053

Drug Name

DOXYCYCLINE

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2000-11-22

65053 / 2

Active Ingredient

DOXYCYCLINE

Application Number

65053

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2000-11-22

Regulatory Status

RX

2003
10 Sep
RX Application: 65053

Drug Name

DOXYCYCLINE

Product Number

3

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2003-09-10

65053 / 3

Active Ingredient

DOXYCYCLINE

Application Number

65053

Product Number

3

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2003-09-10

Regulatory Status

RX

2006
31 May
RX Application: 65356

Drug Name

DOXYCYCLINE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2006-05-31

65356 / 1

Active Ingredient

DOXYCYCLINE

Application Number

65356

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2006-05-31

Regulatory Status

RX

2006
31 May
RX Application: 65356

Drug Name

DOXYCYCLINE

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2006-05-31

65356 / 2

Active Ingredient

DOXYCYCLINE

Application Number

65356

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2006-05-31

Regulatory Status

RX

2006
31 May
RX Application: 65356

Drug Name

DOXYCYCLINE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2006-05-31

65356 / 3

Active Ingredient

DOXYCYCLINE

Application Number

65356

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2006-05-31

Regulatory Status

RX

2010
29 Jul
RX Application: 65356

Drug Name

DOXYCYCLINE

Product Number

4

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2010-07-29

65356 / 4

Active Ingredient

DOXYCYCLINE

Application Number

65356

Product Number

4

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2010-07-29

Regulatory Status

RX

2019
19 Jul
RX Application: 212516

Drug Name

DRIZALMA SPRINKLE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2019-07-19

212516 / 1

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

212516

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 212516

Drug Name

DRIZALMA SPRINKLE

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2019-07-19

212516 / 2

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

212516

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 212516

Drug Name

DRIZALMA SPRINKLE

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2019-07-19

212516 / 3

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

212516

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 212516

Drug Name

DRIZALMA SPRINKLE

Product Number

4

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2019-07-19

212516 / 4

Active Ingredient

DULOXETINE HYDROCHLORIDE

Application Number

212516

Product Number

4

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2019-07-19

Regulatory Status

RX

2021
18 Feb
RX Application: 214384

Drug Name

DROXIDOPA

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2021-02-18

214384 / 1

Active Ingredient

DROXIDOPA

Application Number

214384

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2021-02-18

Regulatory Status

RX

2021
18 Feb
RX Application: 214384

Drug Name

DROXIDOPA

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2021-02-18

214384 / 2

Active Ingredient

DROXIDOPA

Application Number

214384

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2021-02-18

Regulatory Status

RX

2021
18 Feb
RX Application: 214384

Drug Name

DROXIDOPA

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2021-02-18

214384 / 3

Active Ingredient

DROXIDOPA

Application Number

214384

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2021-02-18

Regulatory Status

RX

2012
16 Jul
RX Application: 90690

Drug Name

ENTACAPONE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2012-07-16

90690 / 1

Active Ingredient

ENTACAPONE

Application Number

90690

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2012-07-16

Regulatory Status

RX

2021
15 Jan
RX Application: 210473

Drug Name

EPOPROSTENOL SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE/VIAL

Approval Date

2021-01-15

210473 / 1

Active Ingredient

EPOPROSTENOL SODIUM

Application Number

210473

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE/VIAL

Approval Date

2021-01-15

Regulatory Status

RX

2021
15 Jan
RX Application: 210473

Drug Name

EPOPROSTENOL SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 1.5MG BASE/VIAL

Approval Date

2021-01-15

210473 / 2

Active Ingredient

EPOPROSTENOL SODIUM

Application Number

210473

Product Number

2

Dosage Form

-

Strength

EQ 1.5MG BASE/VIAL

Approval Date

2021-01-15

Regulatory Status

RX

2018
30 Apr
RX Application: 209735

Drug Name

ESOMEPRAZOLE MAGNESIUM

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2018-04-30

209735 / 1

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

209735

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2018-04-30

Regulatory Status

RX

2018
30 Apr
RX Application: 209735

Drug Name

ESOMEPRAZOLE MAGNESIUM

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2018-04-30

209735 / 2

Active Ingredient

ESOMEPRAZOLE MAGNESIUM

Application Number

209735

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2018-04-30

Regulatory Status

RX

2013
03 Apr
RX Application: 91103

Drug Name

ESZOPICLONE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2013-04-03

91103 / 1

Active Ingredient

ESZOPICLONE

Application Number

91103

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2013-04-03

Regulatory Status

RX

2013
03 Apr
RX Application: 91103

Drug Name

ESZOPICLONE

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2013-04-03

91103 / 2

Active Ingredient

ESZOPICLONE

Application Number

91103

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2013-04-03

Regulatory Status

RX

2013
03 Apr
RX Application: 91103

Drug Name

ESZOPICLONE

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2013-04-03

91103 / 3

Active Ingredient

ESZOPICLONE

Application Number

91103

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2013-04-03

Regulatory Status

RX

2019
01 Jul
RX Application: 205467

Drug Name

FEBUXOSTAT

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2019-07-01

205467 / 1

Active Ingredient

FEBUXOSTAT

Application Number

205467

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2019-07-01

Regulatory Status

RX

2019
01 Jul
RX Application: 205467

Drug Name

FEBUXOSTAT

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2019-07-01

205467 / 2

Active Ingredient

FEBUXOSTAT

Application Number

205467

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2019-07-01

Regulatory Status

RX

2013
13 Dec
RX Application: 91200

Drug Name

FELODIPINE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2013-12-13

91200 / 1

Active Ingredient

FELODIPINE

Application Number

91200

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2013-12-13

Regulatory Status

RX

2013
13 Dec
RX Application: 91200

Drug Name

FELODIPINE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2013-12-13

91200 / 2

Active Ingredient

FELODIPINE

Application Number

91200

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2013-12-13

Regulatory Status

RX

2013
13 Dec
RX Application: 91200

Drug Name

FELODIPINE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2013-12-13

91200 / 3

Active Ingredient

FELODIPINE

Application Number

91200

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2013-12-13

Regulatory Status

RX

2005
31 Oct
RX Application: 76635

Drug Name

FENOFIBRATE

Product Number

2

Dosage Form

-

Strength

107MG

Approval Date

2005-10-31

76635 / 2

Active Ingredient

FENOFIBRATE

Application Number

76635

Product Number

2

Dosage Form

-

Strength

107MG

Approval Date

2005-10-31

Regulatory Status

RX

2011
16 Aug
RX Application: 90507

Drug Name

FINASTERIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-08-16

90507 / 1

Active Ingredient

FINASTERIDE

Application Number

90507

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-08-16

Regulatory Status

RX

2013
01 Jul
RX Application: 90508

Drug Name

FINASTERIDE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2013-07-01

90508 / 1

Active Ingredient

FINASTERIDE

Application Number

90508

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2013-07-01

Regulatory Status

RX

2003
28 Mar
RX Application: 76421

Drug Name

FLECAINIDE ACETATE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2003-03-28

76421 / 1

Active Ingredient

FLECAINIDE ACETATE

Application Number

76421

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2003-03-28

Regulatory Status

RX

2003
28 Mar
RX Application: 76421

Drug Name

FLECAINIDE ACETATE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2003-03-28

76421 / 2

Active Ingredient

FLECAINIDE ACETATE

Application Number

76421

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2003-03-28

Regulatory Status

RX

2003
28 Mar
RX Application: 76421

Drug Name

FLECAINIDE ACETATE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2003-03-28

76421 / 3

Active Ingredient

FLECAINIDE ACETATE

Application Number

76421

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2003-03-28

Regulatory Status

RX

2019
20 Nov
RX Application: 204024

Drug Name

FOSAMPRENAVIR CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 700MG BASE

Approval Date

2019-11-20

204024 / 1

Active Ingredient

FOSAMPRENAVIR CALCIUM

Application Number

204024

Product Number

1

Dosage Form

-

Strength

EQ 700MG BASE

Approval Date

2019-11-20

Regulatory Status

RX

2008
18 Mar
RX Application: 78417

Drug Name

FOSPHENYTOIN SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 50MG PHENYTOIN NA/ML

Approval Date

2008-03-18

78417 / 1

Active Ingredient

FOSPHENYTOIN SODIUM

Application Number

78417

Product Number

1

Dosage Form

-

Strength

EQ 50MG PHENYTOIN NA/ML

Approval Date

2008-03-18

Regulatory Status

RX

2018
30 Nov
RX Application: 204246

Drug Name

FYREMADEL

Product Number

1

Dosage Form

-

Strength

250MCG/0.5ML

Approval Date

2018-11-30

204246 / 1

Active Ingredient

GANIRELIX ACETATE

Application Number

204246

Product Number

1

Dosage Form

-

Strength

250MCG/0.5ML

Approval Date

2018-11-30

Regulatory Status

RX

2011
02 Feb
RX Application: 90178

Drug Name

GALANTAMINE HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2011-02-02

90178 / 1

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

90178

Product Number

1

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2011-02-02

Regulatory Status

RX

2011
02 Feb
RX Application: 90178

Drug Name

GALANTAMINE HYDROBROMIDE

Product Number

2

Dosage Form

-

Strength

EQ 16MG BASE

Approval Date

2011-02-02

90178 / 2

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

90178

Product Number

2

Dosage Form

-

Strength

EQ 16MG BASE

Approval Date

2011-02-02

Regulatory Status

RX

2011
02 Feb
RX Application: 90178

Drug Name

GALANTAMINE HYDROBROMIDE

Product Number

3

Dosage Form

-

Strength

EQ 24MG BASE

Approval Date

2011-02-02

90178 / 3

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

90178

Product Number

3

Dosage Form

-

Strength

EQ 24MG BASE

Approval Date

2011-02-02

Regulatory Status

RX

2011
25 Jul
RX Application: 78433

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/VIAL

Approval Date

2011-07-25

78433 / 1

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

78433

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/VIAL

Approval Date

2011-07-25

Regulatory Status

RX

2011
25 Jul
RX Application: 78433

Drug Name

GEMCITABINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2011-07-25

78433 / 2

Active Ingredient

GEMCITABINE HYDROCHLORIDE

Application Number

78433

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2011-07-25

Regulatory Status

RX

2009
18 Aug
RX Application: 40844

Drug Name

GLYCOPYRROLATE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2009-08-18

40844 / 1

Active Ingredient

GLYCOPYRROLATE

Application Number

40844

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2009-08-18

Regulatory Status

RX

2009
18 Aug
RX Application: 40844

Drug Name

GLYCOPYRROLATE

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2009-08-18

40844 / 2

Active Ingredient

GLYCOPYRROLATE

Application Number

40844

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2009-08-18

Regulatory Status

RX

1982
01 Jan
RX Application: 17556

Drug Name

HALOG

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

17556 / 1

Active Ingredient

HALCINONIDE

Application Number

17556

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 17823

Drug Name

HALOG

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

17823 / 1

Active Ingredient

HALCINONIDE

Application Number

17823

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

1982-01-01

Regulatory Status

RX

2022
17 Mar
RX Application: 205031

Drug Name

LACOSAMIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2022-03-17

205031 / 1

Active Ingredient

LACOSAMIDE

Application Number

205031

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2022-03-17

Regulatory Status

RX

2022
17 Mar
RX Application: 205031

Drug Name

LACOSAMIDE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2022-03-17

205031 / 2

Active Ingredient

LACOSAMIDE

Application Number

205031

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2022-03-17

Regulatory Status

RX

2022
17 Mar
RX Application: 205031

Drug Name

LACOSAMIDE

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2022-03-17

205031 / 3

Active Ingredient

LACOSAMIDE

Application Number

205031

Product Number

3

Dosage Form

-

Strength

150MG

Approval Date

2022-03-17

Regulatory Status

RX

2022
17 Mar
RX Application: 205031

Drug Name

LACOSAMIDE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2022-03-17

205031 / 4

Active Ingredient

LACOSAMIDE

Application Number

205031

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2022-03-17

Regulatory Status

RX

2023
08 Feb
RX Application: 211846

Drug Name

LENALIDOMIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2023-02-08

211846 / 1

Active Ingredient

LENALIDOMIDE

Application Number

211846

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2023-02-08

Regulatory Status

RX

2023
08 Feb
RX Application: 211846

Drug Name

LENALIDOMIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2023-02-08

211846 / 2

Active Ingredient

LENALIDOMIDE

Application Number

211846

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2023-02-08

Regulatory Status

RX

2023
08 Feb
RX Application: 211846

Drug Name

LENALIDOMIDE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2023-02-08

211846 / 3

Active Ingredient

LENALIDOMIDE

Application Number

211846

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2023-02-08

Regulatory Status

RX

2023
08 Feb
RX Application: 211846

Drug Name

LENALIDOMIDE

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2023-02-08

211846 / 4

Active Ingredient

LENALIDOMIDE

Application Number

211846

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2023-02-08

Regulatory Status

RX

2023
06 Mar
RX Application: 211846

Drug Name

LENALIDOMIDE

Product Number

5

Dosage Form

-

Strength

2.5MG

Approval Date

2023-03-06

211846 / 5

Active Ingredient

LENALIDOMIDE

Application Number

211846

Product Number

5

Dosage Form

-

Strength

2.5MG

Approval Date

2023-03-06

Regulatory Status

RX

2023
06 Mar
RX Application: 211846

Drug Name

LENALIDOMIDE

Product Number

6

Dosage Form

-

Strength

20MG

Approval Date

2023-03-06

211846 / 6

Active Ingredient

LENALIDOMIDE

Application Number

211846

Product Number

6

Dosage Form

-

Strength

20MG

Approval Date

2023-03-06

Regulatory Status

RX

2024
25 Jul
RX Application: 217900

Drug Name

LEQSELVI

Product Number

1

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2024-07-25

217900 / 1

Active Ingredient

DEURUXOLITINIB PHOSPHATE

Application Number

217900

Product Number

1

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2024-07-25

Regulatory Status

RX

2009
09 Mar
RX Application: 78885

Drug Name

LEUPROLIDE ACETATE

Product Number

1

Dosage Form

-

Strength

14MG/2.8ML (1MG/0.2ML)

Approval Date

2009-03-09

78885 / 1

Active Ingredient

LEUPROLIDE ACETATE

Application Number

78885

Product Number

1

Dosage Form

-

Strength

14MG/2.8ML (1MG/0.2ML)

Approval Date

2009-03-09

Regulatory Status

RX

2013
31 Jan
RX Application: 90362

Drug Name

LEVOCETIRIZINE DIHYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2013-01-31

90362 / 1

Active Ingredient

LEVOCETIRIZINE DIHYDROCHLORIDE

Application Number

90362

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2013-01-31

Regulatory Status

RX

2021
17 Jun
RX Application: 213906

Drug Name

LEVORPHANOL TARTRATE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2021-06-17

213906 / 1

Active Ingredient

LEVORPHANOL TARTRATE

Application Number

213906

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2021-06-17

Regulatory Status

RX

2023
25 Apr
RX Application: 213906

Drug Name

LEVORPHANOL TARTRATE

Product Number

2

Dosage Form

-

Strength

3MG

Approval Date

2023-04-25

213906 / 2

Active Ingredient

LEVORPHANOL TARTRATE

Application Number

213906

Product Number

2

Dosage Form

-

Strength

3MG

Approval Date

2023-04-25

Regulatory Status

RX

1999
03 Dec
RX Application: 20965

Drug Name

LEVULAN

Product Number

1

Dosage Form

-

Strength

20%

Approval Date

1999-12-03

20965 / 1

Active Ingredient

AMINOLEVULINIC ACID HYDROCHLORIDE

Application Number

20965

Product Number

1

Dosage Form

-

Strength

20%

Approval Date

1999-12-03

Regulatory Status

RX

2016
20 Apr
RX Application: 91382

Drug Name

LIOTHYRONINE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 0.005MG BASE

Approval Date

2016-04-20

91382 / 1

Active Ingredient

LIOTHYRONINE SODIUM

Application Number

91382

Product Number

1

Dosage Form

-

Strength

EQ 0.005MG BASE

Approval Date

2016-04-20

Regulatory Status

RX

2016
20 Apr
RX Application: 91382

Drug Name

LIOTHYRONINE SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 0.025MG BASE

Approval Date

2016-04-20

91382 / 2

Active Ingredient

LIOTHYRONINE SODIUM

Application Number

91382

Product Number

2

Dosage Form

-

Strength

EQ 0.025MG BASE

Approval Date

2016-04-20

Regulatory Status

RX

2016
20 Apr
RX Application: 91382

Drug Name

LIOTHYRONINE SODIUM

Product Number

3

Dosage Form

-

Strength

EQ 0.05MG BASE

Approval Date

2016-04-20

91382 / 3

Active Ingredient

LIOTHYRONINE SODIUM

Application Number

91382

Product Number

3

Dosage Form

-

Strength

EQ 0.05MG BASE

Approval Date

2016-04-20

Regulatory Status

RX

2023
25 Aug
RX Application: 214134

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2023-08-25

214134 / 1

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

214134

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 214134

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2023-08-25

214134 / 2

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

214134

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 214134

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2023-08-25

214134 / 3

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

214134

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 214134

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2023-08-25

214134 / 4

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

214134

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 214134

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2023-08-25

214134 / 5

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

214134

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 214134

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2023-08-25

214134 / 6

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

214134

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 214484

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2023-08-25

214484 / 1

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

214484

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 214484

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2023-08-25

214484 / 2

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

214484

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 214484

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2023-08-25

214484 / 3

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

214484

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 214484

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2023-08-25

214484 / 4

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

214484

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 214484

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2023-08-25

214484 / 5

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

214484

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 214484

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2023-08-25

214484 / 6

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

214484

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 214484

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

7

Dosage Form

-

Strength

70MG

Approval Date

2023-08-25

214484 / 7

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

214484

Product Number

7

Dosage Form

-

Strength

70MG

Approval Date

2023-08-25

Regulatory Status

RX

2002
01 Jul
RX Application: 75944

Drug Name

LISINOPRIL

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2002-07-01

75944 / 1

Active Ingredient

LISINOPRIL

Application Number

75944

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2002-07-01

Regulatory Status

RX

2002
01 Jul
RX Application: 75944

Drug Name

LISINOPRIL

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2002-07-01

75944 / 2

Active Ingredient

LISINOPRIL

Application Number

75944

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2002-07-01

Regulatory Status

RX

2002
01 Jul
RX Application: 75944

Drug Name

LISINOPRIL

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2002-07-01

75944 / 3

Active Ingredient

LISINOPRIL

Application Number

75944

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2002-07-01

Regulatory Status

RX

2002
01 Jul
RX Application: 75944

Drug Name

LISINOPRIL

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2002-07-01

75944 / 4

Active Ingredient

LISINOPRIL

Application Number

75944

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2002-07-01

Regulatory Status

RX

2002
01 Jul
RX Application: 75944

Drug Name

LISINOPRIL

Product Number

5

Dosage Form

-

Strength

40MG

Approval Date

2002-07-01

75944 / 5

Active Ingredient

LISINOPRIL

Application Number

75944

Product Number

5

Dosage Form

-

Strength

40MG

Approval Date

2002-07-01

Regulatory Status

RX

2003
11 Feb
RX Application: 75944

Drug Name

LISINOPRIL

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2003-02-11

75944 / 6

Active Ingredient

LISINOPRIL

Application Number

75944

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2003-02-11

Regulatory Status

RX

2002
01 Jul
RX Application: 76007

Drug Name

LISINOPRIL AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;10MG

Approval Date

2002-07-01

76007 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; LISINOPRIL

Application Number

76007

Product Number

1

Dosage Form

-

Strength

12.5MG;10MG

Approval Date

2002-07-01

Regulatory Status

RX

2002
01 Jul
RX Application: 76007

Drug Name

LISINOPRIL AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;20MG

Approval Date

2002-07-01

76007 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; LISINOPRIL

Application Number

76007

Product Number

2

Dosage Form

-

Strength

12.5MG;20MG

Approval Date

2002-07-01

Regulatory Status

RX

2002
01 Jul
RX Application: 76007

Drug Name

LISINOPRIL AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;20MG

Approval Date

2002-07-01

76007 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; LISINOPRIL

Application Number

76007

Product Number

3

Dosage Form

-

Strength

25MG;20MG

Approval Date

2002-07-01

Regulatory Status

RX

2001
29 Aug
RX Application: 76045

Drug Name

LORAZEPAM

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2001-08-29

76045 / 1

Active Ingredient

LORAZEPAM

Application Number

76045

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2001-08-29

Regulatory Status

RX

2001
29 Aug
RX Application: 76045

Drug Name

LORAZEPAM

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2001-08-29

76045 / 2

Active Ingredient

LORAZEPAM

Application Number

76045

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2001-08-29

Regulatory Status

RX

2001
29 Aug
RX Application: 76045

Drug Name

LORAZEPAM

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2001-08-29

76045 / 3

Active Ingredient

LORAZEPAM

Application Number

76045

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2001-08-29

Regulatory Status

RX

2021
26 Feb
RX Application: 212450

Drug Name

LOTEPREDNOL ETABONATE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2021-02-26

212450 / 1

Active Ingredient

LOTEPREDNOL ETABONATE

Application Number

212450

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2021-02-26

Regulatory Status

RX

2019
04 Jan
RX Application: 208066

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2019-01-04

208066 / 1

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

208066

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2019-01-04

Regulatory Status

RX

2019
04 Jan
RX Application: 208066

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2019-01-04

208066 / 2

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

208066

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2019-01-04

Regulatory Status

RX

2019
04 Jan
RX Application: 208066

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

60MG

Approval Date

2019-01-04

208066 / 3

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

208066

Product Number

3

Dosage Form

-

Strength

60MG

Approval Date

2019-01-04

Regulatory Status

RX

2019
04 Jan
RX Application: 208066

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

2019-01-04

208066 / 4

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

208066

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

2019-01-04

Regulatory Status

RX

2025
26 Aug
RX Application: 211123

Drug Name

MACITENTAN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2025-08-26

211123 / 1

Active Ingredient

MACITENTAN

Application Number

211123

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2025-08-26

Regulatory Status

RX

2010
05 May
RX Application: 90058

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2010-05-05

90058 / 1

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

90058

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2010-05-05

Regulatory Status

RX

2010
05 May
RX Application: 90058

Drug Name

MEMANTINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2010-05-05

90058 / 2

Active Ingredient

MEMANTINE HYDROCHLORIDE

Application Number

90058

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2010-05-05

Regulatory Status

RX

2019
25 Jan
RX Application: 211858

Drug Name

MESALAMINE

Product Number

1

Dosage Form

-

Strength

1.2GM

Approval Date

2019-01-25

211858 / 1

Active Ingredient

MESALAMINE

Application Number

211858

Product Number

1

Dosage Form

-

Strength

1.2GM

Approval Date

2019-01-25

Regulatory Status

RX

2022
11 May
RX Application: 214585

Drug Name

MESALAMINE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2022-05-11

214585 / 1

Active Ingredient

MESALAMINE

Application Number

214585

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2022-05-11

Regulatory Status

RX

2015
21 May
RX Application: 201749

Drug Name

METHOTREXATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2015-05-21

201749 / 1

Active Ingredient

METHOTREXATE SODIUM

Application Number

201749

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2015-05-21

Regulatory Status

RX

2012
15 Mar
RX Application: 90710

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2012-03-15

90710 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

90710

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2012-03-15

Regulatory Status

RX

2012
15 Mar
RX Application: 90710

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2012-03-15

90710 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

90710

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2012-03-15

Regulatory Status

RX

2012
15 Mar
RX Application: 90710

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2012-03-15

90710 / 3

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

90710

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2012-03-15

Regulatory Status

RX

2023
25 Aug
RX Application: 217229

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

72MG

Approval Date

2023-08-25

217229 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

217229

Product Number

1

Dosage Form

-

Strength

72MG

Approval Date

2023-08-25

Regulatory Status

RX

1996
10 Dec
RX Application: 74644

Drug Name

METOPROLOL TARTRATE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1996-12-10

74644 / 1

Active Ingredient

METOPROLOL TARTRATE

Application Number

74644

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1996-12-10

Regulatory Status

RX

1996
10 Dec
RX Application: 74644

Drug Name

METOPROLOL TARTRATE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1996-12-10

74644 / 2

Active Ingredient

METOPROLOL TARTRATE

Application Number

74644

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1996-12-10

Regulatory Status

RX

2004
22 Apr
RX Application: 76541

Drug Name

MIRTAZAPINE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2004-04-22

76541 / 1

Active Ingredient

MIRTAZAPINE

Application Number

76541

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2004-04-22

Regulatory Status

RX

2004
22 Apr
RX Application: 76541

Drug Name

MIRTAZAPINE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2004-04-22

76541 / 2

Active Ingredient

MIRTAZAPINE

Application Number

76541

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2004-04-22

Regulatory Status

RX

2004
22 Apr
RX Application: 76541

Drug Name

MIRTAZAPINE

Product Number

3

Dosage Form

-

Strength

45MG

Approval Date

2004-04-22

76541 / 3

Active Ingredient

MIRTAZAPINE

Application Number

76541

Product Number

3

Dosage Form

-

Strength

45MG

Approval Date

2004-04-22

Regulatory Status

RX

2004
22 Apr
RX Application: 76541

Drug Name

MIRTAZAPINE

Product Number

4

Dosage Form

-

Strength

7.5MG

Approval Date

2004-04-22

76541 / 4

Active Ingredient

MIRTAZAPINE

Application Number

76541

Product Number

4

Dosage Form

-

Strength

7.5MG

Approval Date

2004-04-22

Regulatory Status

RX

2012
11 May
RX Application: 78761

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2012-05-11

78761 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

78761

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2012-05-11

Regulatory Status

RX

2012
11 May
RX Application: 78761

Drug Name

MORPHINE SULFATE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2012-05-11

78761 / 2

Active Ingredient

MORPHINE SULFATE

Application Number

78761

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2012-05-11

Regulatory Status

RX

2012
11 May
RX Application: 78761

Drug Name

MORPHINE SULFATE

Product Number

3

Dosage Form

-

Strength

60MG

Approval Date

2012-05-11

78761 / 3

Active Ingredient

MORPHINE SULFATE

Application Number

78761

Product Number

3

Dosage Form

-

Strength

60MG

Approval Date

2012-05-11

Regulatory Status

RX

2012
11 May
RX Application: 78761

Drug Name

MORPHINE SULFATE

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2012-05-11

78761 / 4

Active Ingredient

MORPHINE SULFATE

Application Number

78761

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2012-05-11

Regulatory Status

RX

2012
11 May
RX Application: 78761

Drug Name

MORPHINE SULFATE

Product Number

5

Dosage Form

-

Strength

200MG

Approval Date

2012-05-11

78761 / 5

Active Ingredient

MORPHINE SULFATE

Application Number

78761

Product Number

5

Dosage Form

-

Strength

200MG

Approval Date

2012-05-11

Regulatory Status

RX

2000
17 Mar
RX Application: 75523

Drug Name

NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE;EQ 50MG BASE

Approval Date

2000-03-17

75523 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE

Application Number

75523

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE;EQ 50MG BASE

Approval Date

2000-03-17

Regulatory Status

RX

2012
24 Feb
RX Application: 90356

Drug Name

NALTREXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2012-02-24

90356 / 1

Active Ingredient

NALTREXONE HYDROCHLORIDE

Application Number

90356

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2012-02-24

Regulatory Status

RX

2014
23 Apr
RX Application: 200484

Drug Name

NIACIN

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2014-04-23

200484 / 1

Active Ingredient

NIACIN

Application Number

200484

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2014-04-23

Regulatory Status

RX

2014
23 Apr
RX Application: 200484

Drug Name

NIACIN

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2014-04-23

200484 / 2

Active Ingredient

NIACIN

Application Number

200484

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2014-04-23

Regulatory Status

RX

2014
23 Apr
RX Application: 201273

Drug Name

NIACIN

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

2014-04-23

201273 / 1

Active Ingredient

NIACIN

Application Number

201273

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

2014-04-23

Regulatory Status

RX

2015
24 Jul
RX Application: 205266

Drug Name

ODOMZO

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2015-07-24

205266 / 1

Active Ingredient

SONIDEGIB PHOSPHATE

Application Number

205266

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2015-07-24

Regulatory Status

RX

2007
02 Aug
RX Application: 77557

Drug Name

ONDANSETRON

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

2007-08-02

77557 / 1

Active Ingredient

ONDANSETRON

Application Number

77557

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

2007-08-02

Regulatory Status

RX

2007
02 Aug
RX Application: 77557

Drug Name

ONDANSETRON

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

2007-08-02

77557 / 2

Active Ingredient

ONDANSETRON

Application Number

77557

Product Number

2

Dosage Form

-

Strength

8MG

Approval Date

2007-08-02

Regulatory Status

RX

2007
09 Oct
RX Application: 77794

Drug Name

OXCARBAZEPINE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2007-10-09

77794 / 1

Active Ingredient

OXCARBAZEPINE

Application Number

77794

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2007-10-09

Regulatory Status

RX

2007
09 Oct
RX Application: 77794

Drug Name

OXCARBAZEPINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2007-10-09

77794 / 2

Active Ingredient

OXCARBAZEPINE

Application Number

77794

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2007-10-09

Regulatory Status

RX

2007
09 Oct
RX Application: 77794

Drug Name

OXCARBAZEPINE

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2007-10-09

77794 / 3

Active Ingredient

OXCARBAZEPINE

Application Number

77794

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2007-10-09

Regulatory Status

RX

2009
26 Jun
RX Application: 78734

Drug Name

OXCARBAZEPINE

Product Number

1

Dosage Form

-

Strength

300MG/5ML

Approval Date

2009-06-26

78734 / 1

Active Ingredient

OXCARBAZEPINE

Application Number

78734

Product Number

1

Dosage Form

-

Strength

300MG/5ML

Approval Date

2009-06-26

Regulatory Status

RX

2018
06 Apr
RX Application: 205618

Drug Name

PALIPERIDONE

Product Number

1

Dosage Form

-

Strength

1.5mg

Approval Date

2018-04-06

205618 / 1

Active Ingredient

PALIPERIDONE

Application Number

205618

Product Number

1

Dosage Form

-

Strength

1.5mg

Approval Date

2018-04-06

Regulatory Status

RX

2018
06 Apr
RX Application: 205618

Drug Name

PALIPERIDONE

Product Number

2

Dosage Form

-

Strength

3MG

Approval Date

2018-04-06

205618 / 2

Active Ingredient

PALIPERIDONE

Application Number

205618

Product Number

2

Dosage Form

-

Strength

3MG

Approval Date

2018-04-06

Regulatory Status

RX

2018
06 Apr
RX Application: 205618

Drug Name

PALIPERIDONE

Product Number

3

Dosage Form

-

Strength

6MG

Approval Date

2018-04-06

205618 / 3

Active Ingredient

PALIPERIDONE

Application Number

205618

Product Number

3

Dosage Form

-

Strength

6MG

Approval Date

2018-04-06

Regulatory Status

RX

2018
06 Apr
RX Application: 205618

Drug Name

PALIPERIDONE

Product Number

4

Dosage Form

-

Strength

9MG

Approval Date

2018-04-06

205618 / 4

Active Ingredient

PALIPERIDONE

Application Number

205618

Product Number

4

Dosage Form

-

Strength

9MG

Approval Date

2018-04-06

Regulatory Status

RX

2020
30 Jun
RX Application: 213725

Drug Name

PANTOPRAZOLE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2020-06-30

213725 / 1

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

213725

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2020-06-30

Regulatory Status

RX

2023
19 Oct
RX Application: 215837

Drug Name

PAZOPANIB HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2023-10-19

215837 / 1

Active Ingredient

PAZOPANIB HYDROCHLORIDE

Application Number

215837

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2023-10-19

Regulatory Status

RX

2012
27 Mar
RX Application: 201190

Drug Name

QUETIAPINE FUMARATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2012-03-27

201190 / 2

Active Ingredient

QUETIAPINE FUMARATE

Application Number

201190

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2012-03-27

Regulatory Status

RX

2012
27 Mar
RX Application: 201190

Drug Name

QUETIAPINE FUMARATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2012-03-27

201190 / 3

Active Ingredient

QUETIAPINE FUMARATE

Application Number

201190

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2012-03-27

Regulatory Status

RX

2012
27 Mar
RX Application: 201190

Drug Name

QUETIAPINE FUMARATE

Product Number

5

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2012-03-27

201190 / 5

Active Ingredient

QUETIAPINE FUMARATE

Application Number

201190

Product Number

5

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2012-03-27

Regulatory Status

RX

2015
30 Nov
RX Application: 90886

Drug Name

RISEDRONATE SODIUM

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-11-30

90886 / 1

Active Ingredient

RISEDRONATE SODIUM

Application Number

90886

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-11-30

Regulatory Status

RX

2015
30 Nov
RX Application: 90886

Drug Name

RISEDRONATE SODIUM

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2015-11-30

90886 / 2

Active Ingredient

RISEDRONATE SODIUM

Application Number

90886

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2015-11-30

Regulatory Status

RX

2015
30 Nov
RX Application: 90886

Drug Name

RISEDRONATE SODIUM

Product Number

3

Dosage Form

-

Strength

35MG

Approval Date

2015-11-30

90886 / 3

Active Ingredient

RISEDRONATE SODIUM

Application Number

90886

Product Number

3

Dosage Form

-

Strength

35MG

Approval Date

2015-11-30

Regulatory Status

RX

2014
10 Jun
RX Application: 90886

Drug Name

RISEDRONATE SODIUM

Product Number

4

Dosage Form

-

Strength

75MG

Approval Date

2014-06-10

90886 / 4

Active Ingredient

RISEDRONATE SODIUM

Application Number

90886

Product Number

4

Dosage Form

-

Strength

75MG

Approval Date

2014-06-10

Regulatory Status

RX

2014
10 Jun
RX Application: 90886

Drug Name

RISEDRONATE SODIUM

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2014-06-10

90886 / 5

Active Ingredient

RISEDRONATE SODIUM

Application Number

90886

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2014-06-10

Regulatory Status

RX

2010
06 Aug
RX Application: 77542

Drug Name

RISPERIDONE

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2010-08-06

77542 / 1

Active Ingredient

RISPERIDONE

Application Number

77542

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2010-08-06

Regulatory Status

RX

2010
06 Aug
RX Application: 77542

Drug Name

RISPERIDONE

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2010-08-06

77542 / 2

Active Ingredient

RISPERIDONE

Application Number

77542

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2010-08-06

Regulatory Status

RX

2010
06 Aug
RX Application: 77542

Drug Name

RISPERIDONE

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2010-08-06

77542 / 3

Active Ingredient

RISPERIDONE

Application Number

77542

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2010-08-06

Regulatory Status

RX

2010
06 Aug
RX Application: 78474

Drug Name

RISPERIDONE

Product Number

1

Dosage Form

-

Strength

3MG

Approval Date

2010-08-06

78474 / 1

Active Ingredient

RISPERIDONE

Application Number

78474

Product Number

1

Dosage Form

-

Strength

3MG

Approval Date

2010-08-06

Regulatory Status

RX

2010
06 Aug
RX Application: 78474

Drug Name

RISPERIDONE

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2010-08-06

78474 / 2

Active Ingredient

RISPERIDONE

Application Number

78474

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2010-08-06

Regulatory Status

RX

2025
20 Feb
RX Application: 219547

Drug Name

SELENIOUS ACID

Product Number

1

Dosage Form

-

Strength

EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)

Approval Date

2025-02-20

219547 / 1

Active Ingredient

SELENIOUS ACID

Application Number

219547

Product Number

1

Dosage Form

-

Strength

EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)

Approval Date

2025-02-20

Regulatory Status

RX

2022
17 Nov
RX Application: 215910

Drug Name

SEZABY

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2022-11-17

215910 / 1

Active Ingredient

PHENOBARBITAL SODIUM

Application Number

215910

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2022-11-17

Regulatory Status

RX

2026
28 Jul
RX Application: 214319

Drug Name

SUGAMMADEX SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/2ML (EQ 100MG BASE/ML)

Approval Date

2026-07-28

214319 / 1

Active Ingredient

SUGAMMADEX SODIUM

Application Number

214319

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE/2ML (EQ 100MG BASE/ML)

Approval Date

2026-07-28

Regulatory Status

RX

2026
28 Jul
RX Application: 214319

Drug Name

SUGAMMADEX SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/5ML (EQ 100MG BASE/ML)

Approval Date

2026-07-28

214319 / 2

Active Ingredient

SUGAMMADEX SODIUM

Application Number

214319

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/5ML (EQ 100MG BASE/ML)

Approval Date

2026-07-28

Regulatory Status

RX

2018
20 Jul
RX Application: 202803

Drug Name

SUMATRIPTAN AND NAPROXEN SODIUM

Product Number

1

Dosage Form

-

Strength

500MG;EQ 85MG BASE

Approval Date

2018-07-20

202803 / 1

Active Ingredient

NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE

Application Number

202803

Product Number

1

Dosage Form

-

Strength

500MG;EQ 85MG BASE

Approval Date

2018-07-20

Regulatory Status

RX

2011
21 Jun
RX Application: 90358

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

Approval Date

2011-06-21

90358 / 1

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

90358

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

Approval Date

2011-06-21

Regulatory Status

RX

2021
16 Aug
RX Application: 213914

Drug Name

SUNITINIB MALATE

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE

Approval Date

2021-08-16

213914 / 1

Active Ingredient

SUNITINIB MALATE

Application Number

213914

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE

Approval Date

2021-08-16

Regulatory Status

RX

2021
16 Aug
RX Application: 213914

Drug Name

SUNITINIB MALATE

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2021-08-16

213914 / 2

Active Ingredient

SUNITINIB MALATE

Application Number

213914

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2021-08-16

Regulatory Status

RX

2021
16 Aug
RX Application: 213914

Drug Name

SUNITINIB MALATE

Product Number

3

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2021-08-16

213914 / 3

Active Ingredient

SUNITINIB MALATE

Application Number

213914

Product Number

3

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2021-08-16

Regulatory Status

RX

2021
16 Aug
RX Application: 213914

Drug Name

SUNITINIB MALATE

Product Number

4

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2021-08-16

213914 / 4

Active Ingredient

SUNITINIB MALATE

Application Number

213914

Product Number

4

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2021-08-16

Regulatory Status

RX

2019
26 Mar
RX Application: 208934

Drug Name

TADALAFIL

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2019-03-26

208934 / 1

Active Ingredient

TADALAFIL

Application Number

208934

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2019-03-26

Regulatory Status

RX

2019
26 Mar
RX Application: 208934

Drug Name

TADALAFIL

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2019-03-26

208934 / 2

Active Ingredient

TADALAFIL

Application Number

208934

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2019-03-26

Regulatory Status

RX

2019
26 Mar
RX Application: 208934

Drug Name

TADALAFIL

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2019-03-26

208934 / 3

Active Ingredient

TADALAFIL

Application Number

208934

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2019-03-26

Regulatory Status

RX

2019
26 Mar
RX Application: 208934

Drug Name

TADALAFIL

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2019-03-26

208934 / 4

Active Ingredient

TADALAFIL

Application Number

208934

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2019-03-26

Regulatory Status

RX

2008
29 Jan
RX Application: 78242

Drug Name

TECHNETIUM TC-99M MEBROFENIN

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

2008-01-29

78242 / 1

Active Ingredient

TECHNETIUM TC-99M MEBROFENIN KIT

Application Number

78242

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

2008-01-29

Regulatory Status

RX

2019
12 Jul
RX Application: 208994

Drug Name

TECHNETIUM TC99M MERTIATIDE KIT

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

2019-07-12

208994 / 1

Active Ingredient

TECHNETIUM TC-99M MERTIATIDE KIT

Application Number

208994

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

2019-07-12

Regulatory Status

RX

2014
12 Feb
RX Application: 201742

Drug Name

TEMOZOLOMIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2014-02-12

201742 / 1

Active Ingredient

TEMOZOLOMIDE

Application Number

201742

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2014-02-12

Regulatory Status

RX

2014
12 Feb
RX Application: 201742

Drug Name

TEMOZOLOMIDE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2014-02-12

201742 / 2

Active Ingredient

TEMOZOLOMIDE

Application Number

201742

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2014-02-12

Regulatory Status

RX

2014
12 Feb
RX Application: 201742

Drug Name

TEMOZOLOMIDE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2014-02-12

201742 / 3

Active Ingredient

TEMOZOLOMIDE

Application Number

201742

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2014-02-12

Regulatory Status

RX

2014
12 Feb
RX Application: 201742

Drug Name

TEMOZOLOMIDE

Product Number

4

Dosage Form

-

Strength

140MG

Approval Date

2014-02-12

201742 / 4

Active Ingredient

TEMOZOLOMIDE

Application Number

201742

Product Number

4

Dosage Form

-

Strength

140MG

Approval Date

2014-02-12

Regulatory Status

RX

2014
12 Feb
RX Application: 201742

Drug Name

TEMOZOLOMIDE

Product Number

5

Dosage Form

-

Strength

180MG

Approval Date

2014-02-12

201742 / 5

Active Ingredient

TEMOZOLOMIDE

Application Number

201742

Product Number

5

Dosage Form

-

Strength

180MG

Approval Date

2014-02-12

Regulatory Status

RX

2014
12 Feb
RX Application: 201742

Drug Name

TEMOZOLOMIDE

Product Number

6

Dosage Form

-

Strength

250MG

Approval Date

2014-02-12

201742 / 6

Active Ingredient

TEMOZOLOMIDE

Application Number

201742

Product Number

6

Dosage Form

-

Strength

250MG

Approval Date

2014-02-12

Regulatory Status

RX

2003
29 Sep
RX Application: 76416

Drug Name

TIZANIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2003-09-29

76416 / 1

Active Ingredient

TIZANIDINE HYDROCHLORIDE

Application Number

76416

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2003-09-29

Regulatory Status

RX

2003
29 Sep
RX Application: 76416

Drug Name

TIZANIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2003-09-29

76416 / 2

Active Ingredient

TIZANIDINE HYDROCHLORIDE

Application Number

76416

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2003-09-29

Regulatory Status

RX

2019
26 Dec
RX Application: 207136

Drug Name

TOBRAMYCIN

Product Number

1

Dosage Form

-

Strength

300MG/5ML

Approval Date

2019-12-26

207136 / 1

Active Ingredient

TOBRAMYCIN

Application Number

207136

Product Number

1

Dosage Form

-

Strength

300MG/5ML

Approval Date

2019-12-26

Regulatory Status

RX

2026
03 Jun
RX Application: 218407

Drug Name

TOFACITINIB CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2026-06-03

218407 / 1

Active Ingredient

TOFACITINIB CITRATE

Application Number

218407

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

2026-06-03

Regulatory Status

RX

2009
27 Mar
RX Application: 90278

Drug Name

TOPIRAMATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-03-27

90278 / 1

Active Ingredient

TOPIRAMATE

Application Number

90278

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-03-27

Regulatory Status

RX

2009
27 Mar
RX Application: 90278

Drug Name

TOPIRAMATE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2009-03-27

90278 / 2

Active Ingredient

TOPIRAMATE

Application Number

90278

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2009-03-27

Regulatory Status

RX

2009
27 Mar
RX Application: 90278

Drug Name

TOPIRAMATE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2009-03-27

90278 / 3

Active Ingredient

TOPIRAMATE

Application Number

90278

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2009-03-27

Regulatory Status

RX

2002
19 Jun
RX Application: 75964

Drug Name

TRAMADOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2002-06-19

75964 / 1

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

75964

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2002-06-19

Regulatory Status

RX

2007
31 Jan
RX Application: 76588

Drug Name

VALACYCLOVIR HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2007-01-31

76588 / 1

Active Ingredient

VALACYCLOVIR HYDROCHLORIDE

Application Number

76588

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2007-01-31

Regulatory Status

RX

2007
31 Jan
RX Application: 76588

Drug Name

VALACYCLOVIR HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

2007-01-31

76588 / 2

Active Ingredient

VALACYCLOVIR HYDROCHLORIDE

Application Number

76588

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

2007-01-31

Regulatory Status

RX

2009
17 Jun
RX Application: 79001

Drug Name

VECURONIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

10MG/VIAL

Approval Date

2009-06-17

79001 / 1

Active Ingredient

VECURONIUM BROMIDE

Application Number

79001

Product Number

1

Dosage Form

-

Strength

10MG/VIAL

Approval Date

2009-06-17

Regulatory Status

RX

2008
13 Jun
RX Application: 78627

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2008-06-13

78627 / 1

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

78627

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2008-06-13

Regulatory Status

RX

2008
13 Jun
RX Application: 78627

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2008-06-13

78627 / 2

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

78627

Product Number

2

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2008-06-13

Regulatory Status

RX

2008
13 Jun
RX Application: 78627

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2008-06-13

78627 / 3

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

78627

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2008-06-13

Regulatory Status

RX

2008
13 Jun
RX Application: 78627

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2008-06-13

78627 / 4

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

78627

Product Number

4

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2008-06-13

Regulatory Status

RX

2008
13 Jun
RX Application: 78627

Drug Name

VENLAFAXINE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2008-06-13

78627 / 5

Active Ingredient

VENLAFAXINE HYDROCHLORIDE

Application Number

78627

Product Number

5

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2008-06-13

Regulatory Status

RX

2020
26 Aug
RX Application: 213433

Drug Name

WINLEVI

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2020-08-26

213433 / 1

Active Ingredient

CLASCOTERONE

Application Number

213433

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2020-08-26

Regulatory Status

RX

2018
22 May
RX Application: 210308

Drug Name

YONSA

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2018-05-22

210308 / 1

Active Ingredient

ABIRATERONE ACETATE

Application Number

210308

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2018-05-22

Regulatory Status

RX

2017
24 Jan
RX Application: 204170

Drug Name

ZOLPIDEM TARTRATE

Product Number

1

Dosage Form

-

Strength

6.25MG

Approval Date

2017-01-24

204170 / 1

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

204170

Product Number

1

Dosage Form

-

Strength

6.25MG

Approval Date

2017-01-24

Regulatory Status

RX

2017
24 Jan
RX Application: 204170

Drug Name

ZOLPIDEM TARTRATE

Product Number

2

Dosage Form

-

Strength

12.5MG

Approval Date

2017-01-24

204170 / 2

Active Ingredient

ZOLPIDEM TARTRATE

Application Number

204170

Product Number

2

Dosage Form

-

Strength

12.5MG

Approval Date

2017-01-24

Regulatory Status

RX

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Drug Status Breakdown
271 total
  • RX
Official Source

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

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

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

Drug Name

ABSORICA

Application Number

21951

Product Number

1

Active Ingredient

ISOTRETINOIN

Dosage Form

-

Strength

10MG

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

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