Epic Pharma. LLC. RX
FDA Approved Drugs

Epic Pharma. LLC. 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 215
  • Latest Approval Date May 13, 2026
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
360
View
Unclassified
4
View
Discontinued
141
View
RX
215
View
Company Overview

Company

Epic Pharma. LLC. RX

Country

U.S.A

Website

Visit Website

Email

E.Korzik@Epic-Pharma.com

Social Profiles

Company Snapshot

Epic Pharma. LLC. RX

227-15 N. Conduit Ave.Laurelton, NY 11413, USA

U.S.A

www.epic-pharma.com/ E.Korzik@Epic-Pharma.com View on Map
FDA Approved Drug Records ( 215 records )
2024
14 May
RX Application: 218023

Drug Name

ACETAZOLAMIDE

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2024-05-14

218023 / 1

Active Ingredient

ACETAZOLAMIDE

Application Number

218023

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2024-05-14

Regulatory Status

RX

2024
14 May
RX Application: 218023

Drug Name

ACETAZOLAMIDE

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2024-05-14

218023 / 2

Active Ingredient

ACETAZOLAMIDE

Application Number

218023

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2024-05-14

Regulatory Status

RX

2009
08 Apr
RX Application: 78552

Drug Name

AMLODIPINE BESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2009-04-08

78552 / 1

Active Ingredient

AMLODIPINE BESYLATE

Application Number

78552

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2009-04-08

Regulatory Status

RX

2009
08 Apr
RX Application: 78552

Drug Name

AMLODIPINE BESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2009-04-08

78552 / 2

Active Ingredient

AMLODIPINE BESYLATE

Application Number

78552

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2009-04-08

Regulatory Status

RX

2009
08 Apr
RX Application: 78552

Drug Name

AMLODIPINE BESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2009-04-08

78552 / 3

Active Ingredient

AMLODIPINE BESYLATE

Application Number

78552

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2009-04-08

Regulatory Status

RX

2020
27 Oct
RX Application: 213980

Drug Name

AMPHETAMINE SULFATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2020-10-27

213980 / 1

Active Ingredient

AMPHETAMINE SULFATE

Application Number

213980

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2020-10-27

Regulatory Status

RX

2020
27 Oct
RX Application: 213980

Drug Name

AMPHETAMINE SULFATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2020-10-27

213980 / 2

Active Ingredient

AMPHETAMINE SULFATE

Application Number

213980

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2020-10-27

Regulatory Status

RX

2019
17 May
RX Application: 207610

Drug Name

AZELASTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.137MG/SPRAY

Approval Date

2019-05-17

207610 / 1

Active Ingredient

AZELASTINE HYDROCHLORIDE

Application Number

207610

Product Number

1

Dosage Form

-

Strength

0.137MG/SPRAY

Approval Date

2019-05-17

Regulatory Status

RX

2018
09 Apr
RX Application: 207531

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/5ML

Approval Date

2018-04-09

207531 / 1

Active Ingredient

AZITHROMYCIN

Application Number

207531

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/5ML

Approval Date

2018-04-09

Regulatory Status

RX

2018
09 Apr
RX Application: 207531

Drug Name

AZITHROMYCIN

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE/5ML

Approval Date

2018-04-09

207531 / 2

Active Ingredient

AZITHROMYCIN

Application Number

207531

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE/5ML

Approval Date

2018-04-09

Regulatory Status

RX

2015
15 Dec
RX Application: 90346

Drug Name

BENZPHETAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2015-12-15

90346 / 1

Active Ingredient

BENZPHETAMINE HYDROCHLORIDE

Application Number

90346

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2015-12-15

Regulatory Status

RX

1989
27 Feb
RX Application: 72264

Drug Name

BENZTROPINE MESYLATE

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

1989-02-27

72264 / 1

Active Ingredient

BENZTROPINE MESYLATE

Application Number

72264

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

1989-02-27

Regulatory Status

RX

1989
27 Feb
RX Application: 72265

Drug Name

BENZTROPINE MESYLATE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1989-02-27

72265 / 1

Active Ingredient

BENZTROPINE MESYLATE

Application Number

72265

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1989-02-27

Regulatory Status

RX

1989
27 Feb
RX Application: 72266

Drug Name

BENZTROPINE MESYLATE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1989-02-27

72266 / 1

Active Ingredient

BENZTROPINE MESYLATE

Application Number

72266

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

1989-02-27

Regulatory Status

RX

1999
22 Oct
RX Application: 75541

Drug Name

BETAXOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1999-10-22

75541 / 1

Active Ingredient

BETAXOLOL HYDROCHLORIDE

Application Number

75541

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

1999-10-22

Regulatory Status

RX

1999
22 Oct
RX Application: 75541

Drug Name

BETAXOLOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

1999-10-22

75541 / 2

Active Ingredient

BETAXOLOL HYDROCHLORIDE

Application Number

75541

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

1999-10-22

Regulatory Status

RX

2000
25 Sep
RX Application: 75579

Drug Name

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

2.5MG;6.25MG

Approval Date

2000-09-25

75579 / 1

Active Ingredient

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

Application Number

75579

Product Number

1

Dosage Form

-

Strength

2.5MG;6.25MG

Approval Date

2000-09-25

Regulatory Status

RX

2000
25 Sep
RX Application: 75579

Drug Name

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

5MG;6.25MG

Approval Date

2000-09-25

75579 / 2

Active Ingredient

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

Application Number

75579

Product Number

2

Dosage Form

-

Strength

5MG;6.25MG

Approval Date

2000-09-25

Regulatory Status

RX

2000
25 Sep
RX Application: 75579

Drug Name

BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

10MG;6.25MG

Approval Date

2000-09-25

75579 / 3

Active Ingredient

BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE

Application Number

75579

Product Number

3

Dosage Form

-

Strength

10MG;6.25MG

Approval Date

2000-09-25

Regulatory Status

RX

2025
13 Mar
RX Application: 218628

Drug Name

BUCAPSOL

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2025-03-13

218628 / 1

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

218628

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2025-03-13

Regulatory Status

RX

2025
13 Mar
RX Application: 218628

Drug Name

BUCAPSOL

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2025-03-13

218628 / 2

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

218628

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2025-03-13

Regulatory Status

RX

2025
13 Mar
RX Application: 218628

Drug Name

BUCAPSOL

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2025-03-13

218628 / 3

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

218628

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2025-03-13

Regulatory Status

RX

2026
29 Apr
RX Application: 218628

Drug Name

BUCAPSOL

Product Number

4

Dosage Form

-

Strength

5MG

Approval Date

2026-04-29

218628 / 4

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

218628

Product Number

4

Dosage Form

-

Strength

5MG

Approval Date

2026-04-29

Regulatory Status

RX

2003
25 Nov
RX Application: 75932

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2003-11-25

75932 / 1

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

75932

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2003-11-25

Regulatory Status

RX

2004
22 Mar
RX Application: 75932

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2004-03-22

75932 / 2

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

75932

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2004-03-22

Regulatory Status

RX

2005
22 Jun
RX Application: 75932

Drug Name

BUPROPION HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2005-06-22

75932 / 3

Active Ingredient

BUPROPION HYDROCHLORIDE

Application Number

75932

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2005-06-22

Regulatory Status

RX

2019
16 Apr
RX Application: 208972

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-04-16

208972 / 1

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

208972

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-04-16

Regulatory Status

RX

2019
16 Apr
RX Application: 208972

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2019-04-16

208972 / 2

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

208972

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2019-04-16

Regulatory Status

RX

2019
16 Apr
RX Application: 208972

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2019-04-16

208972 / 3

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

208972

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2019-04-16

Regulatory Status

RX

2019
16 Apr
RX Application: 208972

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2019-04-16

208972 / 4

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

208972

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2019-04-16

Regulatory Status

RX

2019
16 Apr
RX Application: 208972

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

2019-04-16

208972 / 5

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

208972

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

2019-04-16

Regulatory Status

RX

2026
13 May
RX Application: 208972

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

2.5MG

Approval Date

2026-05-13

208972 / 6

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

208972

Product Number

6

Dosage Form

-

Strength

2.5MG

Approval Date

2026-05-13

Regulatory Status

RX

2026
13 May
RX Application: 208972

Drug Name

BUSPIRONE HYDROCHLORIDE

Product Number

7

Dosage Form

-

Strength

12.5MG

Approval Date

2026-05-13

208972 / 7

Active Ingredient

BUSPIRONE HYDROCHLORIDE

Application Number

208972

Product Number

7

Dosage Form

-

Strength

12.5MG

Approval Date

2026-05-13

Regulatory Status

RX

2009
29 Jul
RX Application: 90475

Drug Name

CARBOPLATIN

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2009-07-29

90475 / 1

Active Ingredient

CARBOPLATIN

Application Number

90475

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2009-07-29

Regulatory Status

RX

2009
29 Jul
RX Application: 90475

Drug Name

CARBOPLATIN

Product Number

2

Dosage Form

-

Strength

150MG/15ML (10MG/ML)

Approval Date

2009-07-29

90475 / 2

Active Ingredient

CARBOPLATIN

Application Number

90475

Product Number

2

Dosage Form

-

Strength

150MG/15ML (10MG/ML)

Approval Date

2009-07-29

Regulatory Status

RX

2009
29 Jul
RX Application: 90475

Drug Name

CARBOPLATIN

Product Number

3

Dosage Form

-

Strength

450MG/45ML (10MG/ML)

Approval Date

2009-07-29

90475 / 3

Active Ingredient

CARBOPLATIN

Application Number

90475

Product Number

3

Dosage Form

-

Strength

450MG/45ML (10MG/ML)

Approval Date

2009-07-29

Regulatory Status

RX

2010
28 Jul
RX Application: 91268

Drug Name

CARBOPLATIN

Product Number

2

Dosage Form

-

Strength

600MG/60ML (10MG/ML)

Approval Date

2010-07-28

91268 / 2

Active Ingredient

CARBOPLATIN

Application Number

91268

Product Number

2

Dosage Form

-

Strength

600MG/60ML (10MG/ML)

Approval Date

2010-07-28

Regulatory Status

RX

2008
11 Jan
RX Application: 65305

Drug Name

CEFTRIAXONE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

2008-01-11

65305 / 1

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65305

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

2008-01-11

Regulatory Status

RX

2008
11 Jan
RX Application: 65305

Drug Name

CEFTRIAXONE

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2008-01-11

65305 / 2

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65305

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2008-01-11

Regulatory Status

RX

2008
11 Jan
RX Application: 65305

Drug Name

CEFTRIAXONE

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2008-01-11

65305 / 3

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65305

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2008-01-11

Regulatory Status

RX

2008
11 Jan
RX Application: 65305

Drug Name

CEFTRIAXONE

Product Number

4

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2008-01-11

65305 / 4

Active Ingredient

CEFTRIAXONE SODIUM

Application Number

65305

Product Number

4

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2008-01-11

Regulatory Status

RX

2026
29 Apr
RX Application: 218740

Drug Name

CETRORELIX ACETATE

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE/VIAL

Approval Date

2026-04-29

218740 / 1

Active Ingredient

CETRORELIX ACETATE

Application Number

218740

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE/VIAL

Approval Date

2026-04-29

Regulatory Status

RX

1996
15 Aug
RX Application: 74557

Drug Name

CHOLESTYRAMINE

Product Number

1

Dosage Form

-

Strength

EQ 4GM RESIN/PACKET

Approval Date

1996-08-15

74557 / 1

Active Ingredient

CHOLESTYRAMINE

Application Number

74557

Product Number

1

Dosage Form

-

Strength

EQ 4GM RESIN/PACKET

Approval Date

1996-08-15

Regulatory Status

RX

1996
15 Aug
RX Application: 74557

Drug Name

CHOLESTYRAMINE

Product Number

2

Dosage Form

-

Strength

EQ 4GM RESIN/SCOOPFUL

Approval Date

1996-08-15

74557 / 2

Active Ingredient

CHOLESTYRAMINE

Application Number

74557

Product Number

2

Dosage Form

-

Strength

EQ 4GM RESIN/SCOOPFUL

Approval Date

1996-08-15

Regulatory Status

RX

1996
15 Aug
RX Application: 74558

Drug Name

CHOLESTYRAMINE LIGHT

Product Number

1

Dosage Form

-

Strength

EQ 4GM RESIN/PACKET

Approval Date

1996-08-15

74558 / 1

Active Ingredient

CHOLESTYRAMINE

Application Number

74558

Product Number

1

Dosage Form

-

Strength

EQ 4GM RESIN/PACKET

Approval Date

1996-08-15

Regulatory Status

RX

1996
15 Aug
RX Application: 74558

Drug Name

CHOLESTYRAMINE LIGHT

Product Number

2

Dosage Form

-

Strength

EQ 4GM RESIN/SCOOPFUL

Approval Date

1996-08-15

74558 / 2

Active Ingredient

CHOLESTYRAMINE

Application Number

74558

Product Number

2

Dosage Form

-

Strength

EQ 4GM RESIN/SCOOPFUL

Approval Date

1996-08-15

Regulatory Status

RX

2004
23 Nov
RX Application: 77022

Drug Name

CILOSTAZOL

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2004-11-23

77022 / 1

Active Ingredient

CILOSTAZOL

Application Number

77022

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2004-11-23

Regulatory Status

RX

2005
11 Mar
RX Application: 77022

Drug Name

CILOSTAZOL

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2005-03-11

77022 / 2

Active Ingredient

CILOSTAZOL

Application Number

77022

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2005-03-11

Regulatory Status

RX

2005
29 Apr
RX Application: 77045

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2005-04-29

77045 / 1

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

77045

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2005-04-29

Regulatory Status

RX

2005
29 Apr
RX Application: 77045

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2005-04-29

77045 / 2

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

77045

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2005-04-29

Regulatory Status

RX

2005
29 Apr
RX Application: 77045

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2005-04-29

77045 / 3

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

77045

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2005-04-29

Regulatory Status

RX

2004
22 Mar
RX Application: 65194

Drug Name

CLINDAMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2004-03-22

65194 / 1

Active Ingredient

CLINDAMYCIN HYDROCHLORIDE

Application Number

65194

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2004-03-22

Regulatory Status

RX

2004
22 Mar
RX Application: 65194

Drug Name

CLINDAMYCIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2004-03-22

65194 / 2

Active Ingredient

CLINDAMYCIN HYDROCHLORIDE

Application Number

65194

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

2004-03-22

Regulatory Status

RX

2010
17 Jun
RX Application: 65513

Drug Name

CLINDAMYCIN PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 1% BASE

Approval Date

2010-06-17

65513 / 1

Active Ingredient

CLINDAMYCIN PHOSPHATE

Application Number

65513

Product Number

1

Dosage Form

-

Strength

EQ 1% BASE

Approval Date

2010-06-17

Regulatory Status

RX

2024
19 Dec
RX Application: 218644

Drug Name

CYCLOPHOSPHAMIDE

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2024-12-19

218644 / 1

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

218644

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2024-12-19

Regulatory Status

RX

2024
19 Dec
RX Application: 218644

Drug Name

CYCLOPHOSPHAMIDE

Product Number

2

Dosage Form

-

Strength

1GM/VIAL

Approval Date

2024-12-19

218644 / 2

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

218644

Product Number

2

Dosage Form

-

Strength

1GM/VIAL

Approval Date

2024-12-19

Regulatory Status

RX

2024
19 Dec
RX Application: 218644

Drug Name

CYCLOPHOSPHAMIDE

Product Number

3

Dosage Form

-

Strength

2GM/VIAL

Approval Date

2024-12-19

218644 / 3

Active Ingredient

CYCLOPHOSPHAMIDE

Application Number

218644

Product Number

3

Dosage Form

-

Strength

2GM/VIAL

Approval Date

2024-12-19

Regulatory Status

RX

2008
01 Dec
RX Application: 65389

Drug Name

DEMECLOCYCLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2008-12-01

65389 / 1

Active Ingredient

DEMECLOCYCLINE HYDROCHLORIDE

Application Number

65389

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2008-12-01

Regulatory Status

RX

2008
01 Dec
RX Application: 65389

Drug Name

DEMECLOCYCLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2008-12-01

65389 / 2

Active Ingredient

DEMECLOCYCLINE HYDROCHLORIDE

Application Number

65389

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2008-12-01

Regulatory Status

RX

2015
18 Aug
RX Application: 65447

Drug Name

DEMECLOCYCLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2015-08-18

65447 / 1

Active Ingredient

DEMECLOCYCLINE HYDROCHLORIDE

Application Number

65447

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2015-08-18

Regulatory Status

RX

2015
18 Aug
RX Application: 65447

Drug Name

DEMECLOCYCLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2015-08-18

65447 / 2

Active Ingredient

DEMECLOCYCLINE HYDROCHLORIDE

Application Number

65447

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2015-08-18

Regulatory Status

RX

2011
10 Mar
RX Application: 90727

Drug Name

DESOXIMETASONE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2011-03-10

90727 / 1

Active Ingredient

DESOXIMETASONE

Application Number

90727

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2011-03-10

Regulatory Status

RX

2014
24 Apr
RX Application: 201005

Drug Name

DESOXIMETASONE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2014-04-24

201005 / 1

Active Ingredient

DESOXIMETASONE

Application Number

201005

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2014-04-24

Regulatory Status

RX

2002
19 Jun
RX Application: 40444

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2002-06-19

40444 / 1

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

40444

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2002-06-19

Regulatory Status

RX

2002
19 Jun
RX Application: 40444

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

2

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2002-06-19

40444 / 2

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

40444

Product Number

2

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2002-06-19

Regulatory Status

RX

2002
19 Jun
RX Application: 40444

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

3

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2002-06-19

40444 / 3

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

40444

Product Number

3

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2002-06-19

Regulatory Status

RX

2002
19 Jun
RX Application: 40444

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

4

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2002-06-19

40444 / 4

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

40444

Product Number

4

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2002-06-19

Regulatory Status

RX

2014
03 Nov
RX Application: 40444

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

5

Dosage Form

-

Strength

1.875MG;1.875MG;1.875MG;1.875MG

Approval Date

2014-11-03

40444 / 5

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

40444

Product Number

5

Dosage Form

-

Strength

1.875MG;1.875MG;1.875MG;1.875MG

Approval Date

2014-11-03

Regulatory Status

RX

2014
03 Nov
RX Application: 40444

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

6

Dosage Form

-

Strength

3.125MG;3.125MG;3.125MG;3.125MG

Approval Date

2014-11-03

40444 / 6

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

40444

Product Number

6

Dosage Form

-

Strength

3.125MG;3.125MG;3.125MG;3.125MG

Approval Date

2014-11-03

Regulatory Status

RX

2014
03 Nov
RX Application: 40444

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

7

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG

Approval Date

2014-11-03

40444 / 7

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

40444

Product Number

7

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG

Approval Date

2014-11-03

Regulatory Status

RX

2021
28 Jan
RX Application: 206655

Drug Name

DICLOFENAC SODIUM

Product Number

1

Dosage Form

-

Strength

1.5%

Approval Date

2021-01-28

206655 / 1

Active Ingredient

DICLOFENAC SODIUM

Application Number

206655

Product Number

1

Dosage Form

-

Strength

1.5%

Approval Date

2021-01-28

Regulatory Status

RX

2024
14 May
RX Application: 207284

Drug Name

DIFLUPREDNATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2024-05-14

207284 / 1

Active Ingredient

DIFLUPREDNATE

Application Number

207284

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2024-05-14

Regulatory Status

RX

2014
22 Sep
RX Application: 203058

Drug Name

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE;EQ 0.5% BASE

Approval Date

2014-09-22

203058 / 1

Active Ingredient

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

Application Number

203058

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE;EQ 0.5% BASE

Approval Date

2014-09-22

Regulatory Status

RX

2020
16 Oct
RX Application: 210675

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2020-10-16

210675 / 1

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

210675

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2020-10-16

Regulatory Status

RX

2020
16 Oct
RX Application: 210675

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2020-10-16

210675 / 2

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

210675

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2020-10-16

Regulatory Status

RX

2020
16 Oct
RX Application: 210675

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2020-10-16

210675 / 3

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

210675

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2020-10-16

Regulatory Status

RX

2022
03 Mar
RX Application: 210675

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2022-03-03

210675 / 4

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

210675

Product Number

4

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2022-03-03

Regulatory Status

RX

2022
03 Mar
RX Application: 210675

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2022-03-03

210675 / 5

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

210675

Product Number

5

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2022-03-03

Regulatory Status

RX

1982
08 Nov
RX Application: 62269

Drug Name

DOXYCYCLINE HYCLATE

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1982-11-08

62269 / 2

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

62269

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1982-11-08

Regulatory Status

RX

1983
05 Oct
RX Application: 62269

Drug Name

DOXYCYCLINE HYCLATE

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1983-10-05

62269 / 3

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

62269

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1983-10-05

Regulatory Status

RX

2005
13 May
RX Application: 65182

Drug Name

DOXYCYCLINE HYCLATE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2005-05-13

65182 / 1

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

65182

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2005-05-13

Regulatory Status

RX

2020
16 Dec
RX Application: 214207

Drug Name

DOXYCYCLINE HYCLATE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2020-12-16

214207 / 1

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

214207

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2020-12-16

Regulatory Status

RX

2020
16 Dec
RX Application: 214207

Drug Name

DOXYCYCLINE HYCLATE

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2020-12-16

214207 / 2

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

214207

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2020-12-16

Regulatory Status

RX

2009
24 Jun
RX Application: 90163

Drug Name

EPIRUBICIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/25ML (2MG/ML)

Approval Date

2009-06-24

90163 / 1

Active Ingredient

EPIRUBICIN HYDROCHLORIDE

Application Number

90163

Product Number

1

Dosage Form

-

Strength

50MG/25ML (2MG/ML)

Approval Date

2009-06-24

Regulatory Status

RX

2010
12 May
RX Application: 90215

Drug Name

ERYTHROMYCIN

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2010-05-12

90215 / 1

Active Ingredient

ERYTHROMYCIN

Application Number

90215

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2010-05-12

Regulatory Status

RX

2025
08 Jan
RX Application: 214046

Drug Name

ESOMEPRAZOLE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2025-01-08

214046 / 1

Active Ingredient

ESOMEPRAZOLE SODIUM

Application Number

214046

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2025-01-08

Regulatory Status

RX

1998
29 Dec
RX Application: 40275

Drug Name

ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

1998-12-29

40275 / 1

Active Ingredient

ESTRADIOL

Application Number

40275

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

1998-12-29

Regulatory Status

RX

1998
29 Dec
RX Application: 40275

Drug Name

ESTRADIOL

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

1998-12-29

40275 / 2

Active Ingredient

ESTRADIOL

Application Number

40275

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

1998-12-29

Regulatory Status

RX

1998
29 Dec
RX Application: 40275

Drug Name

ESTRADIOL

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

1998-12-29

40275 / 3

Active Ingredient

ESTRADIOL

Application Number

40275

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

1998-12-29

Regulatory Status

RX

1999
30 Nov
RX Application: 75095

Drug Name

ETHAMBUTOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1999-11-30

75095 / 1

Active Ingredient

ETHAMBUTOL HYDROCHLORIDE

Application Number

75095

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1999-11-30

Regulatory Status

RX

1999
30 Nov
RX Application: 75095

Drug Name

ETHAMBUTOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

1999-11-30

75095 / 2

Active Ingredient

ETHAMBUTOL HYDROCHLORIDE

Application Number

75095

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

1999-11-30

Regulatory Status

RX

2008
28 May
RX Application: 40686

Drug Name

ETHOSUXIMIDE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2008-05-28

40686 / 1

Active Ingredient

ETHOSUXIMIDE

Application Number

40686

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2008-05-28

Regulatory Status

RX

2024
16 Oct
RX Application: 218344

Drug Name

FAMOTIDINE

Product Number

1

Dosage Form

-

Strength

40MG/5ML

Approval Date

2024-10-16

218344 / 1

Active Ingredient

FAMOTIDINE

Application Number

218344

Product Number

1

Dosage Form

-

Strength

40MG/5ML

Approval Date

2024-10-16

Regulatory Status

RX

2005
30 Nov
RX Application: 76835

Drug Name

FLAVOXATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2005-11-30

76835 / 1

Active Ingredient

FLAVOXATE HYDROCHLORIDE

Application Number

76835

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2005-11-30

Regulatory Status

RX

1982
01 Jan
RX Application: 18569

Drug Name

FUROSEMIDE

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1982-01-01

18569 / 1

Active Ingredient

FUROSEMIDE

Application Number

18569

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 18569

Drug Name

FUROSEMIDE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

1982-01-01

18569 / 2

Active Ingredient

FUROSEMIDE

Application Number

18569

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

1982-01-01

Regulatory Status

RX

1984
14 Aug
RX Application: 18569

Drug Name

FUROSEMIDE

Product Number

5

Dosage Form

-

Strength

80MG

Approval Date

1984-08-14

18569 / 5

Active Ingredient

FUROSEMIDE

Application Number

18569

Product Number

5

Dosage Form

-

Strength

80MG

Approval Date

1984-08-14

Regulatory Status

RX

2024
26 Feb
RX Application: 216252

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2024-02-26

216252 / 1

Active Ingredient

GABAPENTIN

Application Number

216252

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2024-02-26

Regulatory Status

RX

2024
26 Feb
RX Application: 216252

Drug Name

GABAPENTIN

Product Number

2

Dosage Form

-

Strength

600MG

Approval Date

2024-02-26

216252 / 2

Active Ingredient

GABAPENTIN

Application Number

216252

Product Number

2

Dosage Form

-

Strength

600MG

Approval Date

2024-02-26

Regulatory Status

RX

2007
26 Mar
RX Application: 78012

Drug Name

GEMFIBROZIL

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2007-03-26

78012 / 1

Active Ingredient

GEMFIBROZIL

Application Number

78012

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2007-03-26

Regulatory Status

RX

2005
27 Oct
RX Application: 77507

Drug Name

GLIPIZIDE AND METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5MG;250MG

Approval Date

2005-10-27

77507 / 1

Active Ingredient

GLIPIZIDE; METFORMIN HYDROCHLORIDE

Application Number

77507

Product Number

1

Dosage Form

-

Strength

2.5MG;250MG

Approval Date

2005-10-27

Regulatory Status

RX

2005
27 Oct
RX Application: 77507

Drug Name

GLIPIZIDE AND METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

2.5MG;500MG

Approval Date

2005-10-27

77507 / 2

Active Ingredient

GLIPIZIDE; METFORMIN HYDROCHLORIDE

Application Number

77507

Product Number

2

Dosage Form

-

Strength

2.5MG;500MG

Approval Date

2005-10-27

Regulatory Status

RX

2005
27 Oct
RX Application: 77507

Drug Name

GLIPIZIDE AND METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

5MG;500MG

Approval Date

2005-10-27

77507 / 3

Active Ingredient

GLIPIZIDE; METFORMIN HYDROCHLORIDE

Application Number

77507

Product Number

3

Dosage Form

-

Strength

5MG;500MG

Approval Date

2005-10-27

Regulatory Status

RX

2002
27 Jun
RX Application: 76257

Drug Name

GLYBURIDE

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

2002-06-27

76257 / 1

Active Ingredient

GLYBURIDE

Application Number

76257

Product Number

1

Dosage Form

-

Strength

1.25MG

Approval Date

2002-06-27

Regulatory Status

RX

2002
27 Jun
RX Application: 76257

Drug Name

GLYBURIDE

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2002-06-27

76257 / 2

Active Ingredient

GLYBURIDE

Application Number

76257

Product Number

2

Dosage Form

-

Strength

2.5MG

Approval Date

2002-06-27

Regulatory Status

RX

2002
27 Jun
RX Application: 76257

Drug Name

GLYBURIDE

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2002-06-27

76257 / 3

Active Ingredient

GLYBURIDE

Application Number

76257

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2002-06-27

Regulatory Status

RX

1997
28 Feb
RX Application: 74673

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

1997-02-28

74673 / 1

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

74673

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

1997-02-28

Regulatory Status

RX

1997
28 Feb
RX Application: 74673

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

1997-02-28

74673 / 2

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

74673

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

1997-02-28

Regulatory Status

RX

2018
30 Mar
RX Application: 203863

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

2018-03-30

203863 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

203863

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

2018-03-30

Regulatory Status

RX

2018
30 Mar
RX Application: 203863

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2018-03-30

203863 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

203863

Product Number

2

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2018-03-30

Regulatory Status

RX

2018
30 Mar
RX Application: 203863

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

325MG;10MG

Approval Date

2018-03-30

203863 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

203863

Product Number

3

Dosage Form

-

Strength

325MG;10MG

Approval Date

2018-03-30

Regulatory Status

RX

2004
28 Dec
RX Application: 40604

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-12-28

40604 / 1

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

40604

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2004-12-28

Regulatory Status

RX

2004
28 Dec
RX Application: 40604

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2004-12-28

40604 / 2

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

40604

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2004-12-28

Regulatory Status

RX

2004
28 Dec
RX Application: 40604

Drug Name

HYDROXYZINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

2004-12-28

40604 / 3

Active Ingredient

HYDROXYZINE HYDROCHLORIDE

Application Number

40604

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

2004-12-28

Regulatory Status

RX

2009
16 Sep
RX Application: 90726

Drug Name

IRINOTECAN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

40MG/2ML (20MG/ML)

Approval Date

2009-09-16

90726 / 1

Active Ingredient

IRINOTECAN HYDROCHLORIDE

Application Number

90726

Product Number

1

Dosage Form

-

Strength

40MG/2ML (20MG/ML)

Approval Date

2009-09-16

Regulatory Status

RX

2009
16 Sep
RX Application: 90726

Drug Name

IRINOTECAN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG/5ML (20MG/ML)

Approval Date

2009-09-16

90726 / 2

Active Ingredient

IRINOTECAN HYDROCHLORIDE

Application Number

90726

Product Number

2

Dosage Form

-

Strength

100MG/5ML (20MG/ML)

Approval Date

2009-09-16

Regulatory Status

RX

2025
09 Sep
RX Application: 218805

Drug Name

IVERMECTIN

Product Number

1

Dosage Form

-

Strength

3MG

Approval Date

2025-09-09

218805 / 1

Active Ingredient

IVERMECTIN

Application Number

218805

Product Number

1

Dosage Form

-

Strength

3MG

Approval Date

2025-09-09

Regulatory Status

RX

2018
30 Apr
RX Application: 210532

Drug Name

KLAYESTA

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM

Approval Date

2018-04-30

210532 / 1

Active Ingredient

NYSTATIN

Application Number

210532

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM

Approval Date

2018-04-30

Regulatory Status

RX

2020
30 Sep
RX Application: 212990

Drug Name

LABETALOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2020-09-30

212990 / 1

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

212990

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2020-09-30

Regulatory Status

RX

2020
30 Sep
RX Application: 212990

Drug Name

LABETALOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2020-09-30

212990 / 2

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

212990

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2020-09-30

Regulatory Status

RX

2020
30 Sep
RX Application: 212990

Drug Name

LABETALOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2020-09-30

212990 / 3

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

212990

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

2020-09-30

Regulatory Status

RX

2018
10 Apr
RX Application: 206375

Drug Name

LAMIVUDINE AND ZIDOVUDINE

Product Number

1

Dosage Form

-

Strength

150MG;300MG

Approval Date

2018-04-10

206375 / 1

Active Ingredient

LAMIVUDINE; ZIDOVUDINE

Application Number

206375

Product Number

1

Dosage Form

-

Strength

150MG;300MG

Approval Date

2018-04-10

Regulatory Status

RX

1997
28 Aug
RX Application: 74544

Drug Name

LEUCOVORIN CALCIUM

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1997-08-28

74544 / 1

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

74544

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1997-08-28

Regulatory Status

RX

1997
28 Aug
RX Application: 74544

Drug Name

LEUCOVORIN CALCIUM

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

1997-08-28

74544 / 2

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

74544

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

1997-08-28

Regulatory Status

RX

2021
19 May
RX Application: 74544

Drug Name

LEUCOVORIN CALCIUM

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2021-05-19

74544 / 3

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

74544

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2021-05-19

Regulatory Status

RX

2021
19 May
RX Application: 74544

Drug Name

LEUCOVORIN CALCIUM

Product Number

4

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2021-05-19

74544 / 4

Active Ingredient

LEUCOVORIN CALCIUM

Application Number

74544

Product Number

4

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2021-05-19

Regulatory Status

RX

2001
17 Dec
RX Application: 75636

Drug Name

LOVASTATIN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2001-12-17

75636 / 1

Active Ingredient

LOVASTATIN

Application Number

75636

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2001-12-17

Regulatory Status

RX

2001
17 Dec
RX Application: 75636

Drug Name

LOVASTATIN

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2001-12-17

75636 / 2

Active Ingredient

LOVASTATIN

Application Number

75636

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2001-12-17

Regulatory Status

RX

2001
17 Dec
RX Application: 75636

Drug Name

LOVASTATIN

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2001-12-17

75636 / 3

Active Ingredient

LOVASTATIN

Application Number

75636

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2001-12-17

Regulatory Status

RX

2012
13 Apr
RX Application: 200294

Drug Name

MECLIZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2012-04-13

200294 / 1

Active Ingredient

MECLIZINE HYDROCHLORIDE

Application Number

200294

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2012-04-13

Regulatory Status

RX

2012
13 Apr
RX Application: 200294

Drug Name

MECLIZINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2012-04-13

200294 / 2

Active Ingredient

MECLIZINE HYDROCHLORIDE

Application Number

200294

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2012-04-13

Regulatory Status

RX

1999
28 May
RX Application: 40331

Drug Name

MEPERIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1999-05-28

40331 / 1

Active Ingredient

MEPERIDINE HYDROCHLORIDE

Application Number

40331

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1999-05-28

Regulatory Status

RX

1999
28 May
RX Application: 40331

Drug Name

MEPERIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1999-05-28

40331 / 2

Active Ingredient

MEPERIDINE HYDROCHLORIDE

Application Number

40331

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1999-05-28

Regulatory Status

RX

2002
25 Jan
RX Application: 75965

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2002-01-25

75965 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

75965

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2002-01-25

Regulatory Status

RX

2002
25 Jan
RX Application: 75965

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

850MG

Approval Date

2002-01-25

75965 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

75965

Product Number

2

Dosage Form

-

Strength

850MG

Approval Date

2002-01-25

Regulatory Status

RX

2002
25 Jan
RX Application: 75965

Drug Name

METFORMIN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

1GM

Approval Date

2002-01-25

75965 / 3

Active Ingredient

METFORMIN HYDROCHLORIDE

Application Number

75965

Product Number

3

Dosage Form

-

Strength

1GM

Approval Date

2002-01-25

Regulatory Status

RX

2015
18 Aug
RX Application: 90065

Drug Name

METHADONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-08-18

90065 / 1

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

90065

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-08-18

Regulatory Status

RX

2015
18 Aug
RX Application: 90065

Drug Name

METHADONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2015-08-18

90065 / 2

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

90065

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2015-08-18

Regulatory Status

RX

2015
20 Mar
RX Application: 90453

Drug Name

MOLINDONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-03-20

90453 / 1

Active Ingredient

MOLINDONE HYDROCHLORIDE

Application Number

90453

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-03-20

Regulatory Status

RX

2015
20 Mar
RX Application: 90453

Drug Name

MOLINDONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2015-03-20

90453 / 2

Active Ingredient

MOLINDONE HYDROCHLORIDE

Application Number

90453

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2015-03-20

Regulatory Status

RX

2015
20 Mar
RX Application: 90453

Drug Name

MOLINDONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

2015-03-20

90453 / 3

Active Ingredient

MOLINDONE HYDROCHLORIDE

Application Number

90453

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

2015-03-20

Regulatory Status

RX

1998
19 Mar
RX Application: 74928

Drug Name

NICARDIPINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1998-03-19

74928 / 1

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

74928

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1998-03-19

Regulatory Status

RX

1998
19 Mar
RX Application: 74928

Drug Name

NICARDIPINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

1998-03-19

74928 / 2

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

74928

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

1998-03-19

Regulatory Status

RX

2002
05 Jul
RX Application: 76178

Drug Name

NIZATIDINE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2002-07-05

76178 / 1

Active Ingredient

NIZATIDINE

Application Number

76178

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2002-07-05

Regulatory Status

RX

2002
05 Jul
RX Application: 76178

Drug Name

NIZATIDINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2002-07-05

76178 / 2

Active Ingredient

NIZATIDINE

Application Number

76178

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2002-07-05

Regulatory Status

RX

2017
04 Aug
RX Application: 207217

Drug Name

NYSTATIN AND TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM;0.1%

Approval Date

2017-08-04

207217 / 1

Active Ingredient

NYSTATIN; TRIAMCINOLONE ACETONIDE

Application Number

207217

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/GM;0.1%

Approval Date

2017-08-04

Regulatory Status

RX

2012
16 Nov
RX Application: 78901

Drug Name

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE;EQ 6MG BASE

Approval Date

2012-11-16

78901 / 1

Active Ingredient

FLUOXETINE HYDROCHLORIDE; OLANZAPINE

Application Number

78901

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE;EQ 6MG BASE

Approval Date

2012-11-16

Regulatory Status

RX

2012
16 Nov
RX Application: 78901

Drug Name

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE;EQ 6MG BASE

Approval Date

2012-11-16

78901 / 2

Active Ingredient

FLUOXETINE HYDROCHLORIDE; OLANZAPINE

Application Number

78901

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE;EQ 6MG BASE

Approval Date

2012-11-16

Regulatory Status

RX

2012
16 Nov
RX Application: 78901

Drug Name

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 25MG BASE;EQ 12MG BASE

Approval Date

2012-11-16

78901 / 3

Active Ingredient

FLUOXETINE HYDROCHLORIDE; OLANZAPINE

Application Number

78901

Product Number

3

Dosage Form

-

Strength

EQ 25MG BASE;EQ 12MG BASE

Approval Date

2012-11-16

Regulatory Status

RX

2012
16 Nov
RX Application: 78901

Drug Name

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 50MG BASE;EQ 12MG BASE

Approval Date

2012-11-16

78901 / 4

Active Ingredient

FLUOXETINE HYDROCHLORIDE; OLANZAPINE

Application Number

78901

Product Number

4

Dosage Form

-

Strength

EQ 50MG BASE;EQ 12MG BASE

Approval Date

2012-11-16

Regulatory Status

RX

2012
16 Nov
RX Application: 78901

Drug Name

OLANZAPINE AND FLUOXETINE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

EQ 25MG BASE;EQ 3MG BASE

Approval Date

2012-11-16

78901 / 5

Active Ingredient

FLUOXETINE HYDROCHLORIDE; OLANZAPINE

Application Number

78901

Product Number

5

Dosage Form

-

Strength

EQ 25MG BASE;EQ 3MG BASE

Approval Date

2012-11-16

Regulatory Status

RX

2021
01 Oct
RX Application: 215208

Drug Name

OSELTAMIVIR PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2021-10-01

215208 / 1

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

215208

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2021-10-01

Regulatory Status

RX

2021
01 Oct
RX Application: 215208

Drug Name

OSELTAMIVIR PHOSPHATE

Product Number

2

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2021-10-01

215208 / 2

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

215208

Product Number

2

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2021-10-01

Regulatory Status

RX

2021
01 Oct
RX Application: 215208

Drug Name

OSELTAMIVIR PHOSPHATE

Product Number

3

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2021-10-01

215208 / 3

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

215208

Product Number

3

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2021-10-01

Regulatory Status

RX

2023
14 Feb
RX Application: 215538

Drug Name

OSELTAMIVIR PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/ML

Approval Date

2023-02-14

215538 / 1

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

215538

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/ML

Approval Date

2023-02-14

Regulatory Status

RX

1988
19 Apr
RX Application: 71756

Drug Name

OXAZEPAM

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1988-04-19

71756 / 1

Active Ingredient

OXAZEPAM

Application Number

71756

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1988-04-19

Regulatory Status

RX

1988
19 Apr
RX Application: 71756

Drug Name

OXAZEPAM

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1988-04-19

71756 / 2

Active Ingredient

OXAZEPAM

Application Number

71756

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1988-04-19

Regulatory Status

RX

1988
19 Apr
RX Application: 71756

Drug Name

OXAZEPAM

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

1988-04-19

71756 / 3

Active Ingredient

OXAZEPAM

Application Number

71756

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

1988-04-19

Regulatory Status

RX

2026
02 Mar
RX Application: 219556

Drug Name

OXCARBAZEPINE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2026-03-02

219556 / 1

Active Ingredient

OXCARBAZEPINE

Application Number

219556

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2026-03-02

Regulatory Status

RX

2026
02 Mar
RX Application: 219556

Drug Name

OXCARBAZEPINE

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2026-03-02

219556 / 2

Active Ingredient

OXCARBAZEPINE

Application Number

219556

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2026-03-02

Regulatory Status

RX

2026
02 Mar
RX Application: 219556

Drug Name

OXCARBAZEPINE

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2026-03-02

219556 / 3

Active Ingredient

OXCARBAZEPINE

Application Number

219556

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2026-03-02

Regulatory Status

RX

2018
02 Jul
RX Application: 203864

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

2018-07-02

203864 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

203864

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

2018-07-02

Regulatory Status

RX

2018
02 Jul
RX Application: 203864

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2018-07-02

203864 / 2

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

203864

Product Number

2

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2018-07-02

Regulatory Status

RX

2018
02 Jul
RX Application: 203864

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

325MG;10MG

Approval Date

2018-07-02

203864 / 3

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

203864

Product Number

3

Dosage Form

-

Strength

325MG;10MG

Approval Date

2018-07-02

Regulatory Status

RX

2009
24 Aug
RX Application: 90895

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2009-08-24

90895 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

90895

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2009-08-24

Regulatory Status

RX

2009
24 Aug
RX Application: 90895

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2009-08-24

90895 / 2

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

90895

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2009-08-24

Regulatory Status

RX

2009
24 Aug
RX Application: 90895

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2009-08-24

90895 / 3

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

90895

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2009-08-24

Regulatory Status

RX

2015
22 Sep
RX Application: 202662

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-09-22

202662 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

202662

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-09-22

Regulatory Status

RX

2015
22 Sep
RX Application: 202662

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2015-09-22

202662 / 2

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

202662

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2015-09-22

Regulatory Status

RX

2015
22 Sep
RX Application: 202662

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2015-09-22

202662 / 3

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

202662

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2015-09-22

Regulatory Status

RX

2015
22 Sep
RX Application: 202662

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2015-09-22

202662 / 4

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

202662

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2015-09-22

Regulatory Status

RX

2017
27 Apr
RX Application: 202662

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2017-04-27

202662 / 5

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

202662

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2017-04-27

Regulatory Status

RX

2014
15 Dec
RX Application: 201187

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2014-12-15

201187 / 1

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

201187

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2014-12-15

Regulatory Status

RX

2014
15 Dec
RX Application: 201187

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2014-12-15

201187 / 2

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

201187

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2014-12-15

Regulatory Status

RX

2012
08 Nov
RX Application: 79197

Drug Name

PANTOPRAZOLE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2012-11-08

79197 / 1

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

79197

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2012-11-08

Regulatory Status

RX

2014
28 Nov
RX Application: 40884

Drug Name

PHENYTOIN

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2014-11-28

40884 / 1

Active Ingredient

PHENYTOIN

Application Number

40884

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2014-11-28

Regulatory Status

RX

2018
23 Nov
RX Application: 210200

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

20MEQ

Approval Date

2018-11-23

210200 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

210200

Product Number

1

Dosage Form

-

Strength

20MEQ

Approval Date

2018-11-23

Regulatory Status

RX

2023
01 Jun
RX Application: 214496

Drug Name

PREGABALIN

Product Number

1

Dosage Form

-

Strength

82.5MG

Approval Date

2023-06-01

214496 / 1

Active Ingredient

PREGABALIN

Application Number

214496

Product Number

1

Dosage Form

-

Strength

82.5MG

Approval Date

2023-06-01

Regulatory Status

RX

2023
01 Jun
RX Application: 214496

Drug Name

PREGABALIN

Product Number

2

Dosage Form

-

Strength

165MG

Approval Date

2023-06-01

214496 / 2

Active Ingredient

PREGABALIN

Application Number

214496

Product Number

2

Dosage Form

-

Strength

165MG

Approval Date

2023-06-01

Regulatory Status

RX

2023
01 Jun
RX Application: 214496

Drug Name

PREGABALIN

Product Number

3

Dosage Form

-

Strength

330MG

Approval Date

2023-06-01

214496 / 3

Active Ingredient

PREGABALIN

Application Number

214496

Product Number

3

Dosage Form

-

Strength

330MG

Approval Date

2023-06-01

Regulatory Status

RX

2012
19 Nov
RX Application: 202220

Drug Name

PROTRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2012-11-19

202220 / 1

Active Ingredient

PROTRIPTYLINE HYDROCHLORIDE

Application Number

202220

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2012-11-19

Regulatory Status

RX

2012
19 Nov
RX Application: 202220

Drug Name

PROTRIPTYLINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2012-11-19

202220 / 2

Active Ingredient

PROTRIPTYLINE HYDROCHLORIDE

Application Number

202220

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2012-11-19

Regulatory Status

RX

1983
26 Sep
RX Application: 88072

Drug Name

QUINIDINE SULFATE

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1983-09-26

88072 / 1

Active Ingredient

QUINIDINE SULFATE

Application Number

88072

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1983-09-26

Regulatory Status

RX

1982
01 Jan
RX Application: 88072

Drug Name

QUINIDINE SULFATE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

88072 / 2

Active Ingredient

QUINIDINE SULFATE

Application Number

88072

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

RX

1997
28 May
RX Application: 64150

Drug Name

RIFAMPIN

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1997-05-28

64150 / 1

Active Ingredient

RIFAMPIN

Application Number

64150

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1997-05-28

Regulatory Status

RX

1998
02 Jan
RX Application: 64150

Drug Name

RIFAMPIN

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

1998-01-02

64150 / 2

Active Ingredient

RIFAMPIN

Application Number

64150

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

1998-01-02

Regulatory Status

RX

2010
21 Sep
RX Application: 65502

Drug Name

RIFAMPIN

Product Number

1

Dosage Form

-

Strength

600MG/VIAL

Approval Date

2010-09-21

65502 / 1

Active Ingredient

RIFAMPIN

Application Number

65502

Product Number

1

Dosage Form

-

Strength

600MG/VIAL

Approval Date

2010-09-21

Regulatory Status

RX

2014
19 Mar
RX Application: 202333

Drug Name

SODIUM POLYSTYRENE SULFONATE

Product Number

1

Dosage Form

-

Strength

453.6GM/BOT

Approval Date

2014-03-19

202333 / 1

Active Ingredient

SODIUM POLYSTYRENE SULFONATE

Application Number

202333

Product Number

1

Dosage Form

-

Strength

453.6GM/BOT

Approval Date

2014-03-19

Regulatory Status

RX

2005
04 Nov
RX Application: 77070

Drug Name

SOTALOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

2005-11-04

77070 / 1

Active Ingredient

SOTALOL HYDROCHLORIDE

Application Number

77070

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

2005-11-04

Regulatory Status

RX

2005
04 Nov
RX Application: 77070

Drug Name

SOTALOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

2005-11-04

77070 / 2

Active Ingredient

SOTALOL HYDROCHLORIDE

Application Number

77070

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

2005-11-04

Regulatory Status

RX

2005
04 Nov
RX Application: 77070

Drug Name

SOTALOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2005-11-04

77070 / 3

Active Ingredient

SOTALOL HYDROCHLORIDE

Application Number

77070

Product Number

3

Dosage Form

-

Strength

160MG

Approval Date

2005-11-04

Regulatory Status

RX

1994
29 Jul
RX Application: 40091

Drug Name

SULFADIAZINE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1994-07-29

40091 / 1

Active Ingredient

SULFADIAZINE

Application Number

40091

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

1994-07-29

Regulatory Status

RX

1991
25 Mar
RX Application: 72711

Drug Name

SULINDAC

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1991-03-25

72711 / 1

Active Ingredient

SULINDAC

Application Number

72711

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1991-03-25

Regulatory Status

RX

1991
25 Mar
RX Application: 72711

Drug Name

SULINDAC

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

1991-03-25

72711 / 2

Active Ingredient

SULINDAC

Application Number

72711

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

1991-03-25

Regulatory Status

RX

2026
27 Jan
RX Application: 214378

Drug Name

TAPENTADOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2026-01-27

214378 / 1

Active Ingredient

TAPENTADOL HYDROCHLORIDE

Application Number

214378

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2026-01-27

Regulatory Status

RX

2026
27 Jan
RX Application: 214378

Drug Name

TAPENTADOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2026-01-27

214378 / 2

Active Ingredient

TAPENTADOL HYDROCHLORIDE

Application Number

214378

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2026-01-27

Regulatory Status

RX

2026
27 Jan
RX Application: 214378

Drug Name

TAPENTADOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2026-01-27

214378 / 3

Active Ingredient

TAPENTADOL HYDROCHLORIDE

Application Number

214378

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2026-01-27

Regulatory Status

RX

2020
11 Sep
RX Application: 212291

Drug Name

TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2020-09-11

212291 / 1

Active Ingredient

TIMOLOL MALEATE

Application Number

212291

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2020-09-11

Regulatory Status

RX

2002
11 Oct
RX Application: 76347

Drug Name

TIZANIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2002-10-11

76347 / 1

Active Ingredient

TIZANIDINE HYDROCHLORIDE

Application Number

76347

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2002-10-11

Regulatory Status

RX

2002
11 Oct
RX Application: 76347

Drug Name

TIZANIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2002-10-11

76347 / 2

Active Ingredient

TIZANIDINE HYDROCHLORIDE

Application Number

76347

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2002-10-11

Regulatory Status

RX

2008
18 Jun
RX Application: 78508

Drug Name

TRANDOLAPRIL

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2008-06-18

78508 / 1

Active Ingredient

TRANDOLAPRIL

Application Number

78508

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2008-06-18

Regulatory Status

RX

2008
18 Jun
RX Application: 78508

Drug Name

TRANDOLAPRIL

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2008-06-18

78508 / 2

Active Ingredient

TRANDOLAPRIL

Application Number

78508

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2008-06-18

Regulatory Status

RX

2008
18 Jun
RX Application: 78508

Drug Name

TRANDOLAPRIL

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2008-06-18

78508 / 3

Active Ingredient

TRANDOLAPRIL

Application Number

78508

Product Number

3

Dosage Form

-

Strength

1MG

Approval Date

2008-06-18

Regulatory Status

RX

2011
17 Nov
RX Application: 202373

Drug Name

TRANEXAMIC ACID

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2011-11-17

202373 / 1

Active Ingredient

TRANEXAMIC ACID

Application Number

202373

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2011-11-17

Regulatory Status

RX

2013
08 May
RX Application: 202374

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

2013-05-08

202374 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

202374

Product Number

1

Dosage Form

-

Strength

0.025%

Approval Date

2013-05-08

Regulatory Status

RX

2013
08 May
RX Application: 202374

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

2

Dosage Form

-

Strength

0.1%

Approval Date

2013-05-08

202374 / 2

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

202374

Product Number

2

Dosage Form

-

Strength

0.1%

Approval Date

2013-05-08

Regulatory Status

RX

1998
17 Dec
RX Application: 65006

Drug Name

TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE

Product Number

1

Dosage Form

-

Strength

10,000 UNITS/ML;EQ 1MG BASE/ML

Approval Date

1998-12-17

65006 / 1

Active Ingredient

POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE

Application Number

65006

Product Number

1

Dosage Form

-

Strength

10,000 UNITS/ML;EQ 1MG BASE/ML

Approval Date

1998-12-17

Regulatory Status

RX

2000
29 Sep
RX Application: 40314

Drug Name

TROPICACYL

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2000-09-29

40314 / 1

Active Ingredient

TROPICAMIDE

Application Number

40314

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2000-09-29

Regulatory Status

RX

2000
14 Mar
RX Application: 75517

Drug Name

URSODIOL

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2000-03-14

75517 / 1

Active Ingredient

URSODIOL

Application Number

75517

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2000-03-14

Regulatory Status

RX

2024
14 Aug
RX Application: 214717

Drug Name

URSODIOL

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2024-08-14

214717 / 1

Active Ingredient

URSODIOL

Application Number

214717

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2024-08-14

Regulatory Status

RX

2024
14 Aug
RX Application: 214717

Drug Name

URSODIOL

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2024-08-14

214717 / 2

Active Ingredient

URSODIOL

Application Number

214717

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2024-08-14

Regulatory Status

RX

2016
07 Sep
RX Application: 207049

Drug Name

VORICONAZOLE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2016-09-07

207049 / 1

Active Ingredient

VORICONAZOLE

Application Number

207049

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2016-09-07

Regulatory Status

RX

2016
07 Sep
RX Application: 207049

Drug Name

VORICONAZOLE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2016-09-07

207049 / 2

Active Ingredient

VORICONAZOLE

Application Number

207049

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2016-09-07

Regulatory Status

RX

2014
21 Aug
RX Application: 200918

Drug Name

ZOLEDRONIC ACID

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/100ML

Approval Date

2014-08-21

200918 / 1

Active Ingredient

ZOLEDRONIC ACID

Application Number

200918

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/100ML

Approval Date

2014-08-21

Regulatory Status

RX

2014
22 May
RX Application: 202548

Drug Name

ZOLEDRONIC ACID

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/5ML

Approval Date

2014-05-22

202548 / 1

Active Ingredient

ZOLEDRONIC ACID

Application Number

202548

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/5ML

Approval Date

2014-05-22

Regulatory Status

RX

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Drug Status Breakdown
215 total
  • RX
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

ACETAZOLAMIDE

Application Number

218023

Product Number

1

Active Ingredient

ACETAZOLAMIDE

Dosage Form

-

Strength

125MG

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

Structured Database

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