InvaGen Pharmaceuticals Inc RX
FDA Approved Drugs

InvaGen Pharmaceuticals Inc 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 105
  • Latest Approval Date Feb 20, 2026
  • Data Source FDA
  • First Approval Date Apr 20, 2005
All
170
View
Unclassified
2
View
Discontinued
63
View
RX
105
View
Company Overview

Company

InvaGen Pharmaceuticals Inc RX

Country

U.S.A

Website

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Company Snapshot

InvaGen Pharmaceuticals Inc RX

7 Oser Avenue ,Hauppauge, NY 11788

U.S.A

www.invagen.com/ View on Map
FDA Approved Drug Records ( 105 records )
2012
17 Jan
RX Application: 90284

Drug Name

ALFUZOSIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2012-01-17

90284 / 1

Active Ingredient

ALFUZOSIN HYDROCHLORIDE

Application Number

90284

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2012-01-17

Regulatory Status

RX

2007
28 Aug
RX Application: 77955

Drug Name

AMLODIPINE BESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2007-08-28

77955 / 1

Active Ingredient

AMLODIPINE BESYLATE

Application Number

77955

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2007-08-28

Regulatory Status

RX

2007
28 Aug
RX Application: 77955

Drug Name

AMLODIPINE BESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2007-08-28

77955 / 2

Active Ingredient

AMLODIPINE BESYLATE

Application Number

77955

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2007-08-28

Regulatory Status

RX

2007
28 Aug
RX Application: 77955

Drug Name

AMLODIPINE BESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-08-28

77955 / 3

Active Ingredient

AMLODIPINE BESYLATE

Application Number

77955

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2007-08-28

Regulatory Status

RX

2015
10 Dec
RX Application: 206367

Drug Name

AMLODIPINE BESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2015-12-10

206367 / 1

Active Ingredient

AMLODIPINE BESYLATE

Application Number

206367

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2015-12-10

Regulatory Status

RX

2015
10 Dec
RX Application: 206367

Drug Name

AMLODIPINE BESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2015-12-10

206367 / 2

Active Ingredient

AMLODIPINE BESYLATE

Application Number

206367

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2015-12-10

Regulatory Status

RX

2015
10 Dec
RX Application: 206367

Drug Name

AMLODIPINE BESYLATE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2015-12-10

206367 / 3

Active Ingredient

AMLODIPINE BESYLATE

Application Number

206367

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2015-12-10

Regulatory Status

RX

2013
07 Feb
RX Application: 203135

Drug Name

CALCIUM ACETATE

Product Number

1

Dosage Form

-

Strength

667MG

Approval Date

2013-02-07

203135 / 1

Active Ingredient

CALCIUM ACETATE

Application Number

203135

Product Number

1

Dosage Form

-

Strength

667MG

Approval Date

2013-02-07

Regulatory Status

RX

2006
03 Oct
RX Application: 77534

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2006-10-03

77534 / 1

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

77534

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2006-10-03

Regulatory Status

RX

2006
03 Oct
RX Application: 77534

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2006-10-03

77534 / 2

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

77534

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2006-10-03

Regulatory Status

RX

2006
03 Oct
RX Application: 77534

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2006-10-03

77534 / 3

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

77534

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2006-10-03

Regulatory Status

RX

2010
23 Jul
RX Application: 90478

Drug Name

CYCLOBENZAPRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2010-07-23

90478 / 1

Active Ingredient

CYCLOBENZAPRINE HYDROCHLORIDE

Application Number

90478

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2010-07-23

Regulatory Status

RX

2010
23 Jul
RX Application: 90478

Drug Name

CYCLOBENZAPRINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2010-07-23

90478 / 2

Active Ingredient

CYCLOBENZAPRINE HYDROCHLORIDE

Application Number

90478

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2010-07-23

Regulatory Status

RX

2012
11 Sep
RX Application: 78604

Drug Name

ESCITALOPRAM OXALATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-09-11

78604 / 1

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

78604

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2012-09-11

Regulatory Status

RX

2012
11 Sep
RX Application: 78604

Drug Name

ESCITALOPRAM OXALATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-09-11

78604 / 2

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

78604

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2012-09-11

Regulatory Status

RX

2012
11 Sep
RX Application: 78604

Drug Name

ESCITALOPRAM OXALATE

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-09-11

78604 / 3

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

78604

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2012-09-11

Regulatory Status

RX

2005
20 Apr
RX Application: 77222

Drug Name

FOSINOPRIL SODIUM

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2005-04-20

77222 / 1

Active Ingredient

FOSINOPRIL SODIUM

Application Number

77222

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2005-04-20

Regulatory Status

RX

2005
20 Apr
RX Application: 77222

Drug Name

FOSINOPRIL SODIUM

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2005-04-20

77222 / 2

Active Ingredient

FOSINOPRIL SODIUM

Application Number

77222

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2005-04-20

Regulatory Status

RX

2005
20 Apr
RX Application: 77222

Drug Name

FOSINOPRIL SODIUM

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2005-04-20

77222 / 3

Active Ingredient

FOSINOPRIL SODIUM

Application Number

77222

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2005-04-20

Regulatory Status

RX

2009
09 Jul
RX Application: 90228

Drug Name

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

10MG;12.5MG

Approval Date

2009-07-09

90228 / 1

Active Ingredient

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

Application Number

90228

Product Number

1

Dosage Form

-

Strength

10MG;12.5MG

Approval Date

2009-07-09

Regulatory Status

RX

2009
09 Jul
RX Application: 90228

Drug Name

FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

20MG;12.5MG

Approval Date

2009-07-09

90228 / 2

Active Ingredient

FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE

Application Number

90228

Product Number

2

Dosage Form

-

Strength

20MG;12.5MG

Approval Date

2009-07-09

Regulatory Status

RX

2009
30 Dec
RX Application: 90705

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2009-12-30

90705 / 1

Active Ingredient

GABAPENTIN

Application Number

90705

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2009-12-30

Regulatory Status

RX

2009
30 Dec
RX Application: 90705

Drug Name

GABAPENTIN

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2009-12-30

90705 / 2

Active Ingredient

GABAPENTIN

Application Number

90705

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2009-12-30

Regulatory Status

RX

2009
30 Dec
RX Application: 90705

Drug Name

GABAPENTIN

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2009-12-30

90705 / 3

Active Ingredient

GABAPENTIN

Application Number

90705

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

2009-12-30

Regulatory Status

RX

2006
27 Jul
RX Application: 77836

Drug Name

GEMFIBROZIL

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2006-07-27

77836 / 1

Active Ingredient

GEMFIBROZIL

Application Number

77836

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

2006-07-27

Regulatory Status

RX

2021
17 Dec
RX Application: 215395

Drug Name

LANREOTIDE ACETATE

Product Number

1

Dosage Form

-

Strength

EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)

Approval Date

2021-12-17

215395 / 1

Active Ingredient

LANREOTIDE ACETATE

Application Number

215395

Product Number

1

Dosage Form

-

Strength

EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)

Approval Date

2021-12-17

Regulatory Status

RX

2021
17 Dec
RX Application: 215395

Drug Name

LANREOTIDE ACETATE

Product Number

2

Dosage Form

-

Strength

EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)

Approval Date

2021-12-17

215395 / 2

Active Ingredient

LANREOTIDE ACETATE

Application Number

215395

Product Number

2

Dosage Form

-

Strength

EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)

Approval Date

2021-12-17

Regulatory Status

RX

2021
17 Dec
RX Application: 215395

Drug Name

LANREOTIDE ACETATE

Product Number

3

Dosage Form

-

Strength

EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)

Approval Date

2021-12-17

215395 / 3

Active Ingredient

LANREOTIDE ACETATE

Application Number

215395

Product Number

3

Dosage Form

-

Strength

EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)

Approval Date

2021-12-17

Regulatory Status

RX

2024
21 May
RX Application: 217193

Drug Name

LANREOTIDE ACETATE

Product Number

1

Dosage Form

-

Strength

EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)

Approval Date

2024-05-21

217193 / 1

Active Ingredient

LANREOTIDE ACETATE

Application Number

217193

Product Number

1

Dosage Form

-

Strength

EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)

Approval Date

2024-05-21

Regulatory Status

RX

2024
21 May
RX Application: 217193

Drug Name

LANREOTIDE ACETATE

Product Number

2

Dosage Form

-

Strength

EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)

Approval Date

2024-05-21

217193 / 2

Active Ingredient

LANREOTIDE ACETATE

Application Number

217193

Product Number

2

Dosage Form

-

Strength

EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)

Approval Date

2024-05-21

Regulatory Status

RX

2024
21 May
RX Application: 217193

Drug Name

LANREOTIDE ACETATE

Product Number

3

Dosage Form

-

Strength

EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)

Approval Date

2024-05-21

217193 / 3

Active Ingredient

LANREOTIDE ACETATE

Application Number

217193

Product Number

3

Dosage Form

-

Strength

EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)

Approval Date

2024-05-21

Regulatory Status

RX

2022
24 Jan
RX Application: 206868

Drug Name

LANTHANUM CARBONATE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2022-01-24

206868 / 1

Active Ingredient

LANTHANUM CARBONATE

Application Number

206868

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2022-01-24

Regulatory Status

RX

2022
24 Jan
RX Application: 206868

Drug Name

LANTHANUM CARBONATE

Product Number

2

Dosage Form

-

Strength

EQ 750MG BASE

Approval Date

2022-01-24

206868 / 2

Active Ingredient

LANTHANUM CARBONATE

Application Number

206868

Product Number

2

Dosage Form

-

Strength

EQ 750MG BASE

Approval Date

2022-01-24

Regulatory Status

RX

2022
24 Jan
RX Application: 206868

Drug Name

LANTHANUM CARBONATE

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

2022-01-24

206868 / 3

Active Ingredient

LANTHANUM CARBONATE

Application Number

206868

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

2022-01-24

Regulatory Status

RX

2018
28 Aug
RX Application: 205054

Drug Name

LEUPROLIDE ACETATE FOR DEPOT SUSPENSION

Product Number

1

Dosage Form

-

Strength

22.5MG/VIAL

Approval Date

2018-08-28

205054 / 1

Active Ingredient

LEUPROLIDE ACETATE

Application Number

205054

Product Number

1

Dosage Form

-

Strength

22.5MG/VIAL

Approval Date

2018-08-28

Regulatory Status

RX

2024
03 Sep
RX Application: 208423

Drug Name

LINAGLIPTIN

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2024-09-03

208423 / 1

Active Ingredient

LINAGLIPTIN

Application Number

208423

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2024-09-03

Regulatory Status

RX

2013
29 Oct
RX Application: 203508

Drug Name

LISINOPRIL

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2013-10-29

203508 / 1

Active Ingredient

LISINOPRIL

Application Number

203508

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2013-10-29

Regulatory Status

RX

2013
29 Oct
RX Application: 203508

Drug Name

LISINOPRIL

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2013-10-29

203508 / 2

Active Ingredient

LISINOPRIL

Application Number

203508

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2013-10-29

Regulatory Status

RX

2013
29 Oct
RX Application: 203508

Drug Name

LISINOPRIL

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2013-10-29

203508 / 3

Active Ingredient

LISINOPRIL

Application Number

203508

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2013-10-29

Regulatory Status

RX

2013
29 Oct
RX Application: 203508

Drug Name

LISINOPRIL

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2013-10-29

203508 / 4

Active Ingredient

LISINOPRIL

Application Number

203508

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2013-10-29

Regulatory Status

RX

2013
29 Oct
RX Application: 203508

Drug Name

LISINOPRIL

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

2013-10-29

203508 / 5

Active Ingredient

LISINOPRIL

Application Number

203508

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

2013-10-29

Regulatory Status

RX

2013
29 Oct
RX Application: 203508

Drug Name

LISINOPRIL

Product Number

6

Dosage Form

-

Strength

40MG

Approval Date

2013-10-29

203508 / 6

Active Ingredient

LISINOPRIL

Application Number

203508

Product Number

6

Dosage Form

-

Strength

40MG

Approval Date

2013-10-29

Regulatory Status

RX

2017
23 May
RX Application: 204058

Drug Name

LISINOPRIL AND HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

12.5MG;10MG

Approval Date

2017-05-23

204058 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; LISINOPRIL

Application Number

204058

Product Number

1

Dosage Form

-

Strength

12.5MG;10MG

Approval Date

2017-05-23

Regulatory Status

RX

2017
23 May
RX Application: 204058

Drug Name

LISINOPRIL AND HYDROCHLOROTHIAZIDE

Product Number

2

Dosage Form

-

Strength

12.5MG;20MG

Approval Date

2017-05-23

204058 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; LISINOPRIL

Application Number

204058

Product Number

2

Dosage Form

-

Strength

12.5MG;20MG

Approval Date

2017-05-23

Regulatory Status

RX

2017
23 May
RX Application: 204058

Drug Name

LISINOPRIL AND HYDROCHLOROTHIAZIDE

Product Number

3

Dosage Form

-

Strength

25MG;20MG

Approval Date

2017-05-23

204058 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; LISINOPRIL

Application Number

204058

Product Number

3

Dosage Form

-

Strength

25MG;20MG

Approval Date

2017-05-23

Regulatory Status

RX

2019
03 Jan
RX Application: 208028

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2019-01-03

208028 / 1

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

208028

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2019-01-03

Regulatory Status

RX

2019
03 Jan
RX Application: 208028

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2019-01-03

208028 / 2

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

208028

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2019-01-03

Regulatory Status

RX

2019
03 Jan
RX Application: 208028

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

60MG

Approval Date

2019-01-03

208028 / 3

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

208028

Product Number

3

Dosage Form

-

Strength

60MG

Approval Date

2019-01-03

Regulatory Status

RX

2019
03 Jan
RX Application: 208028

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

2019-01-03

208028 / 4

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

208028

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

2019-01-03

Regulatory Status

RX

2019
03 Jan
RX Application: 208028

Drug Name

LURASIDONE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

120MG

Approval Date

2019-01-03

208028 / 5

Active Ingredient

LURASIDONE HYDROCHLORIDE

Application Number

208028

Product Number

5

Dosage Form

-

Strength

120MG

Approval Date

2019-01-03

Regulatory Status

RX

2008
27 Feb
RX Application: 40797

Drug Name

MEPROBAMATE

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2008-02-27

40797 / 1

Active Ingredient

MEPROBAMATE

Application Number

40797

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2008-02-27

Regulatory Status

RX

2008
27 Feb
RX Application: 40797

Drug Name

MEPROBAMATE

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

2008-02-27

40797 / 2

Active Ingredient

MEPROBAMATE

Application Number

40797

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

2008-02-27

Regulatory Status

RX

2008
07 Mar
RX Application: 78671

Drug Name

NABUMETONE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2008-03-07

78671 / 1

Active Ingredient

NABUMETONE

Application Number

78671

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2008-03-07

Regulatory Status

RX

2008
07 Mar
RX Application: 78671

Drug Name

NABUMETONE

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2008-03-07

78671 / 2

Active Ingredient

NABUMETONE

Application Number

78671

Product Number

2

Dosage Form

-

Strength

750MG

Approval Date

2008-03-07

Regulatory Status

RX

2015
18 Dec
RX Application: 203455

Drug Name

NADOLOL

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2015-12-18

203455 / 1

Active Ingredient

NADOLOL

Application Number

203455

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2015-12-18

Regulatory Status

RX

2015
18 Dec
RX Application: 203455

Drug Name

NADOLOL

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2015-12-18

203455 / 2

Active Ingredient

NADOLOL

Application Number

203455

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2015-12-18

Regulatory Status

RX

2015
18 Dec
RX Application: 203455

Drug Name

NADOLOL

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

2015-12-18

203455 / 3

Active Ingredient

NADOLOL

Application Number

203455

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

2015-12-18

Regulatory Status

RX

2021
30 Aug
RX Application: 212858

Drug Name

OSELTAMIVIR PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/ML

Approval Date

2021-08-30

212858 / 1

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

212858

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/ML

Approval Date

2021-08-30

Regulatory Status

RX

2023
03 Oct
RX Application: 217467

Drug Name

OSELTAMIVIR PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2023-10-03

217467 / 1

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

217467

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2023-10-03

Regulatory Status

RX

2023
03 Oct
RX Application: 217467

Drug Name

OSELTAMIVIR PHOSPHATE

Product Number

2

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2023-10-03

217467 / 2

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

217467

Product Number

2

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2023-10-03

Regulatory Status

RX

2023
03 Oct
RX Application: 217467

Drug Name

OSELTAMIVIR PHOSPHATE

Product Number

3

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2023-10-03

217467 / 3

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

217467

Product Number

3

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2023-10-03

Regulatory Status

RX

2021
19 Aug
RX Application: 213293

Drug Name

PENICILLAMINE

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2021-08-19

213293 / 1

Active Ingredient

PENICILLAMINE

Application Number

213293

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2021-08-19

Regulatory Status

RX

2019
19 Jul
RX Application: 211384

Drug Name

PREGABALIN

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2019-07-19

211384 / 1

Active Ingredient

PREGABALIN

Application Number

211384

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 211384

Drug Name

PREGABALIN

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2019-07-19

211384 / 2

Active Ingredient

PREGABALIN

Application Number

211384

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 211384

Drug Name

PREGABALIN

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2019-07-19

211384 / 3

Active Ingredient

PREGABALIN

Application Number

211384

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 211384

Drug Name

PREGABALIN

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2019-07-19

211384 / 4

Active Ingredient

PREGABALIN

Application Number

211384

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 211384

Drug Name

PREGABALIN

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2019-07-19

211384 / 5

Active Ingredient

PREGABALIN

Application Number

211384

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 211384

Drug Name

PREGABALIN

Product Number

6

Dosage Form

-

Strength

200MG

Approval Date

2019-07-19

211384 / 6

Active Ingredient

PREGABALIN

Application Number

211384

Product Number

6

Dosage Form

-

Strength

200MG

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 211384

Drug Name

PREGABALIN

Product Number

7

Dosage Form

-

Strength

225MG

Approval Date

2019-07-19

211384 / 7

Active Ingredient

PREGABALIN

Application Number

211384

Product Number

7

Dosage Form

-

Strength

225MG

Approval Date

2019-07-19

Regulatory Status

RX

2019
19 Jul
RX Application: 211384

Drug Name

PREGABALIN

Product Number

8

Dosage Form

-

Strength

300MG

Approval Date

2019-07-19

211384 / 8

Active Ingredient

PREGABALIN

Application Number

211384

Product Number

8

Dosage Form

-

Strength

300MG

Approval Date

2019-07-19

Regulatory Status

RX

2014
24 Sep
RX Application: 90842

Drug Name

RALOXIFENE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2014-09-24

90842 / 1

Active Ingredient

RALOXIFENE HYDROCHLORIDE

Application Number

90842

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2014-09-24

Regulatory Status

RX

2026
20 Feb
RX Application: 218768

Drug Name

RIVAROXABAN

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2026-02-20

218768 / 1

Active Ingredient

RIVAROXABAN

Application Number

218768

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2026-02-20

Regulatory Status

RX

2007
06 Feb
RX Application: 77397

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2007-02-06

77397 / 1

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

77397

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2007-02-06

Regulatory Status

RX

2007
06 Feb
RX Application: 77397

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2007-02-06

77397 / 2

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

77397

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2007-02-06

Regulatory Status

RX

2007
06 Feb
RX Application: 77397

Drug Name

SERTRALINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2007-02-06

77397 / 3

Active Ingredient

SERTRALINE HYDROCHLORIDE

Application Number

77397

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2007-02-06

Regulatory Status

RX

2017
26 Oct
RX Application: 203860

Drug Name

SEVELAMER CARBONATE

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

2017-10-26

203860 / 1

Active Ingredient

SEVELAMER CARBONATE

Application Number

203860

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

2017-10-26

Regulatory Status

RX

2020
06 Aug
RX Application: 213041

Drug Name

SILDENAFIL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2020-08-06

213041 / 1

Active Ingredient

SILDENAFIL CITRATE

Application Number

213041

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2020-08-06

Regulatory Status

RX

2017
13 Nov
RX Application: 206557

Drug Name

SIMVASTATIN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2017-11-13

206557 / 1

Active Ingredient

SIMVASTATIN

Application Number

206557

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2017-11-13

Regulatory Status

RX

2017
13 Nov
RX Application: 206557

Drug Name

SIMVASTATIN

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2017-11-13

206557 / 2

Active Ingredient

SIMVASTATIN

Application Number

206557

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2017-11-13

Regulatory Status

RX

2017
13 Nov
RX Application: 206557

Drug Name

SIMVASTATIN

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2017-11-13

206557 / 3

Active Ingredient

SIMVASTATIN

Application Number

206557

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2017-11-13

Regulatory Status

RX

2017
13 Nov
RX Application: 206557

Drug Name

SIMVASTATIN

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

2017-11-13

206557 / 4

Active Ingredient

SIMVASTATIN

Application Number

206557

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

2017-11-13

Regulatory Status

RX

2025
27 Oct
RX Application: 206557

Drug Name

SIMVASTATIN

Product Number

5

Dosage Form

-

Strength

5MG

Approval Date

2025-10-27

206557 / 5

Active Ingredient

SIMVASTATIN

Application Number

206557

Product Number

5

Dosage Form

-

Strength

5MG

Approval Date

2025-10-27

Regulatory Status

RX

2025
05 May
RX Application: 208537

Drug Name

TICAGRELOR

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2025-05-05

208537 / 1

Active Ingredient

TICAGRELOR

Application Number

208537

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2025-05-05

Regulatory Status

RX

2025
28 Oct
RX Application: 208537

Drug Name

TICAGRELOR

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

2025-10-28

208537 / 2

Active Ingredient

TICAGRELOR

Application Number

208537

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

2025-10-28

Regulatory Status

RX

2009
27 Mar
RX Application: 79162

Drug Name

TOPIRAMATE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-03-27

79162 / 1

Active Ingredient

TOPIRAMATE

Application Number

79162

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2009-03-27

Regulatory Status

RX

2009
27 Mar
RX Application: 79162

Drug Name

TOPIRAMATE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2009-03-27

79162 / 2

Active Ingredient

TOPIRAMATE

Application Number

79162

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2009-03-27

Regulatory Status

RX

2009
27 Mar
RX Application: 79162

Drug Name

TOPIRAMATE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2009-03-27

79162 / 3

Active Ingredient

TOPIRAMATE

Application Number

79162

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2009-03-27

Regulatory Status

RX

2009
27 Mar
RX Application: 79162

Drug Name

TOPIRAMATE

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2009-03-27

79162 / 4

Active Ingredient

TOPIRAMATE

Application Number

79162

Product Number

4

Dosage Form

-

Strength

200MG

Approval Date

2009-03-27

Regulatory Status

RX

2016
23 Aug
RX Application: 91688

Drug Name

TROSPIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2016-08-23

91688 / 1

Active Ingredient

TROSPIUM CHLORIDE

Application Number

91688

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2016-08-23

Regulatory Status

RX

2019
03 Dec
RX Application: 211592

Drug Name

VIGABATRIN

Product Number

1

Dosage Form

-

Strength

500MG/PACKET

Approval Date

2019-12-03

211592 / 1

Active Ingredient

VIGABATRIN

Application Number

211592

Product Number

1

Dosage Form

-

Strength

500MG/PACKET

Approval Date

2019-12-03

Regulatory Status

RX

2021
07 Apr
RX Application: 208200

Drug Name

VILAZODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2021-04-07

208200 / 1

Active Ingredient

VILAZODONE HYDROCHLORIDE

Application Number

208200

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2021-04-07

Regulatory Status

RX

2021
07 Apr
RX Application: 208200

Drug Name

VILAZODONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2021-04-07

208200 / 2

Active Ingredient

VILAZODONE HYDROCHLORIDE

Application Number

208200

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2021-04-07

Regulatory Status

RX

2022
06 Dec
RX Application: 208200

Drug Name

VILAZODONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2022-12-06

208200 / 3

Active Ingredient

VILAZODONE HYDROCHLORIDE

Application Number

208200

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2022-12-06

Regulatory Status

RX

2011
25 May
RX Application: 90935

Drug Name

WARFARIN SODIUM

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2011-05-25

90935 / 1

Active Ingredient

WARFARIN SODIUM

Application Number

90935

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2011-05-25

Regulatory Status

RX

2011
25 May
RX Application: 90935

Drug Name

WARFARIN SODIUM

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2011-05-25

90935 / 2

Active Ingredient

WARFARIN SODIUM

Application Number

90935

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2011-05-25

Regulatory Status

RX

2011
25 May
RX Application: 90935

Drug Name

WARFARIN SODIUM

Product Number

3

Dosage Form

-

Strength

2.5MG

Approval Date

2011-05-25

90935 / 3

Active Ingredient

WARFARIN SODIUM

Application Number

90935

Product Number

3

Dosage Form

-

Strength

2.5MG

Approval Date

2011-05-25

Regulatory Status

RX

2011
25 May
RX Application: 90935

Drug Name

WARFARIN SODIUM

Product Number

4

Dosage Form

-

Strength

3MG

Approval Date

2011-05-25

90935 / 4

Active Ingredient

WARFARIN SODIUM

Application Number

90935

Product Number

4

Dosage Form

-

Strength

3MG

Approval Date

2011-05-25

Regulatory Status

RX

2011
25 May
RX Application: 90935

Drug Name

WARFARIN SODIUM

Product Number

5

Dosage Form

-

Strength

4MG

Approval Date

2011-05-25

90935 / 5

Active Ingredient

WARFARIN SODIUM

Application Number

90935

Product Number

5

Dosage Form

-

Strength

4MG

Approval Date

2011-05-25

Regulatory Status

RX

2011
25 May
RX Application: 90935

Drug Name

WARFARIN SODIUM

Product Number

6

Dosage Form

-

Strength

5MG

Approval Date

2011-05-25

90935 / 6

Active Ingredient

WARFARIN SODIUM

Application Number

90935

Product Number

6

Dosage Form

-

Strength

5MG

Approval Date

2011-05-25

Regulatory Status

RX

2011
25 May
RX Application: 90935

Drug Name

WARFARIN SODIUM

Product Number

7

Dosage Form

-

Strength

6MG

Approval Date

2011-05-25

90935 / 7

Active Ingredient

WARFARIN SODIUM

Application Number

90935

Product Number

7

Dosage Form

-

Strength

6MG

Approval Date

2011-05-25

Regulatory Status

RX

2011
25 May
RX Application: 90935

Drug Name

WARFARIN SODIUM

Product Number

8

Dosage Form

-

Strength

7.5MG

Approval Date

2011-05-25

90935 / 8

Active Ingredient

WARFARIN SODIUM

Application Number

90935

Product Number

8

Dosage Form

-

Strength

7.5MG

Approval Date

2011-05-25

Regulatory Status

RX

2011
25 May
RX Application: 90935

Drug Name

WARFARIN SODIUM

Product Number

9

Dosage Form

-

Strength

10MG

Approval Date

2011-05-25

90935 / 9

Active Ingredient

WARFARIN SODIUM

Application Number

90935

Product Number

9

Dosage Form

-

Strength

10MG

Approval Date

2011-05-25

Regulatory Status

RX

2006
31 May
RX Application: 77869

Drug Name

ZONISAMIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2006-05-31

77869 / 1

Active Ingredient

ZONISAMIDE

Application Number

77869

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2006-05-31

Regulatory Status

RX

2006
31 May
RX Application: 77869

Drug Name

ZONISAMIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2006-05-31

77869 / 2

Active Ingredient

ZONISAMIDE

Application Number

77869

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2006-05-31

Regulatory Status

RX

2006
31 May
RX Application: 77869

Drug Name

ZONISAMIDE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2006-05-31

77869 / 3

Active Ingredient

ZONISAMIDE

Application Number

77869

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2006-05-31

Regulatory Status

RX

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Drug Status Breakdown
105 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

ALFUZOSIN HYDROCHLORIDE

Application Number

90284

Product Number

1

Active Ingredient

ALFUZOSIN HYDROCHLORIDE

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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