Boehringer Ingelheim GmbH
FDA Approved Drugs

Boehringer Ingelheim GmbH

FDA Approved Drugs Database

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

Discontinued RX Unclassified
  • Total Records 120
  • Latest Approval Date Oct 07, 2025
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
120
View
Unclassified
11
View
Discontinued
59
View
RX
50
View
Company Overview

Company

Boehringer Ingelheim GmbH

Country

Germany

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Email

info@boehringer-ingelheim.de

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Company Snapshot

Boehringer Ingelheim GmbH

Corporate Division Communications, Binger Strasse 173, 55216 Ingelheim am Rhein

Germany

www.boehringer-ingelheim.com/ info@boehringer-ingelheim.de View on Map
FDA Approved Drug Records ( 120 records )
1999
22 Nov
Discontinued Application: 20884

Drug Name

AGGRENOX

Product Number

1

Dosage Form

-

Strength

25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-11-22

20884 / 1

Active Ingredient

ASPIRIN; DIPYRIDAMOLE

Application Number

20884

Product Number

1

Dosage Form

-

Strength

25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1999-11-22

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 15874

Drug Name

ALUPENT

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1982-01-01

15874 / 1

Active Ingredient

METAPROTERENOL SULFATE

Application Number

15874

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 15874

Drug Name

ALUPENT

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

15874 / 2

Active Ingredient

METAPROTERENOL SULFATE

Application Number

15874

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16402

Drug Name

ALUPENT

Product Number

1

Dosage Form

-

Strength

0.65MG/INH

Approval Date

1982-01-01

16402 / 1

Active Ingredient

METAPROTERENOL SULFATE

Application Number

16402

Product Number

1

Dosage Form

-

Strength

0.65MG/INH

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17571

Drug Name

ALUPENT

Product Number

1

Dosage Form

-

Strength

10MG/5ML

Approval Date

1982-01-01

17571 / 1

Active Ingredient

METAPROTERENOL SULFATE

Application Number

17571

Product Number

1

Dosage Form

-

Strength

10MG/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17659

Drug Name

ALUPENT

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

1982-01-01

17659 / 1

Active Ingredient

METAPROTERENOL SULFATE

Application Number

17659

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1983
30 Jun
Discontinued Application: 18761

Drug Name

ALUPENT

Product Number

1

Dosage Form

-

Strength

0.6%

Approval Date

1983-06-30

18761 / 1

Active Ingredient

METAPROTERENOL SULFATE

Application Number

18761

Product Number

1

Dosage Form

-

Strength

0.6%

Approval Date

1983-06-30

Regulatory Status

Discontinued

1986
10 Oct
Discontinued Application: 18761

Drug Name

ALUPENT

Product Number

2

Dosage Form

-

Strength

0.4%

Approval Date

1986-10-10

18761 / 2

Active Ingredient

METAPROTERENOL SULFATE

Application Number

18761

Product Number

2

Dosage Form

-

Strength

0.4%

Approval Date

1986-10-10

Regulatory Status

Discontinued

2005
22 Jun
RX Application: 21814

Drug Name

APTIVUS

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2005-06-22

21814 / 1

Active Ingredient

TIPRANAVIR

Application Number

21814

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2005-06-22

Regulatory Status

RX

-
Unclassified Application: 21822

Drug Name

APTIVUS

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

-

21822 / 1

Active Ingredient

TIPRANAVIR

Application Number

21822

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

-

Regulatory Status

Unclassified

2008
23 Jun
Discontinued Application: 22292

Drug Name

APTIVUS

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2008-06-23

22292 / 1

Active Ingredient

TIPRANAVIR

Application Number

22292

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2008-06-23

Regulatory Status

Discontinued

1986
29 Dec
Discontinued Application: 19085

Drug Name

ATROVENT

Product Number

1

Dosage Form

-

Strength

0.018MG/INH

Approval Date

1986-12-29

19085 / 1

Active Ingredient

IPRATROPIUM BROMIDE

Application Number

19085

Product Number

1

Dosage Form

-

Strength

0.018MG/INH

Approval Date

1986-12-29

Regulatory Status

Discontinued

1993
29 Sep
Discontinued Application: 20228

Drug Name

ATROVENT

Product Number

1

Dosage Form

-

Strength

0.02% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-09-29

20228 / 1

Active Ingredient

IPRATROPIUM BROMIDE

Application Number

20228

Product Number

1

Dosage Form

-

Strength

0.02% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1993-09-29

Regulatory Status

Discontinued

1995
20 Oct
Discontinued Application: 20393

Drug Name

ATROVENT

Product Number

1

Dosage Form

-

Strength

0.021MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1995-10-20

20393 / 1

Active Ingredient

IPRATROPIUM BROMIDE

Application Number

20393

Product Number

1

Dosage Form

-

Strength

0.021MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1995-10-20

Regulatory Status

Discontinued

1995
20 Oct
Discontinued Application: 20394

Drug Name

ATROVENT

Product Number

1

Dosage Form

-

Strength

0.042MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1995-10-20

20394 / 1

Active Ingredient

IPRATROPIUM BROMIDE

Application Number

20394

Product Number

1

Dosage Form

-

Strength

0.042MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1995-10-20

Regulatory Status

Discontinued

2004
27 Nov
RX Application: 21527

Drug Name

ATROVENT HFA

Product Number

1

Dosage Form

-

Strength

0.021MG/INH

Approval Date

2004-11-27

21527 / 1

Active Ingredient

IPRATROPIUM BROMIDE

Application Number

21527

Product Number

1

Dosage Form

-

Strength

0.021MG/INH

Approval Date

2004-11-27

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 17407

Drug Name

CATAPRES

Product Number

1

Dosage Form

-

Strength

0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17407 / 1

Active Ingredient

CLONIDINE HYDROCHLORIDE

Application Number

17407

Product Number

1

Dosage Form

-

Strength

0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17407

Drug Name

CATAPRES

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

17407 / 2

Active Ingredient

CLONIDINE HYDROCHLORIDE

Application Number

17407

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17407

Drug Name

CATAPRES

Product Number

3

Dosage Form

-

Strength

0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17407 / 3

Active Ingredient

CLONIDINE HYDROCHLORIDE

Application Number

17407

Product Number

3

Dosage Form

-

Strength

0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17503

Drug Name

COMBIPRES

Product Number

1

Dosage Form

-

Strength

15MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17503 / 1

Active Ingredient

CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE

Application Number

17503

Product Number

1

Dosage Form

-

Strength

15MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17503

Drug Name

COMBIPRES

Product Number

2

Dosage Form

-

Strength

15MG;0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17503 / 2

Active Ingredient

CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE

Application Number

17503

Product Number

2

Dosage Form

-

Strength

15MG;0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
10 Apr
Discontinued Application: 17503

Drug Name

COMBIPRES

Product Number

3

Dosage Form

-

Strength

15MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-04-10

17503 / 3

Active Ingredient

CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE

Application Number

17503

Product Number

3

Dosage Form

-

Strength

15MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-04-10

Regulatory Status

Discontinued

1996
24 Oct
Discontinued Application: 20291

Drug Name

COMBIVENT

Product Number

1

Dosage Form

-

Strength

EQ 0.09MG BASE/INH;0.018MG/INH

Approval Date

1996-10-24

20291 / 1

Active Ingredient

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Application Number

20291

Product Number

1

Dosage Form

-

Strength

EQ 0.09MG BASE/INH;0.018MG/INH

Approval Date

1996-10-24

Regulatory Status

Discontinued

2011
07 Oct
RX Application: 21747

Drug Name

COMBIVENT RESPIMAT

Product Number

1

Dosage Form

-

Strength

EQ 0.1MG BASE/INH;0.02MG/INH

Approval Date

2011-10-07

21747 / 1

Active Ingredient

ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Application Number

21747

Product Number

1

Dosage Form

-

Strength

EQ 0.1MG BASE/INH;0.02MG/INH

Approval Date

2011-10-07

Regulatory Status

RX

-
Unclassified Application: 761058

Drug Name

CYLTEZO

Product Number

1

Dosage Form

-

Strength

40MG/0.8ML

Approval Date

-

761058 / 1

Active Ingredient

ADALIMUMAB-ADBM

Application Number

761058

Product Number

1

Dosage Form

-

Strength

40MG/0.8ML

Approval Date

-

Regulatory Status

Unclassified

2013
12 Jul
RX Application: 201292

Drug Name

GILOTRIF

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2013-07-12

201292 / 1

Active Ingredient

AFATINIB DIMALEATE

Application Number

201292

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2013-07-12

Regulatory Status

RX

2013
12 Jul
RX Application: 201292

Drug Name

GILOTRIF

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2013-07-12

201292 / 2

Active Ingredient

AFATINIB DIMALEATE

Application Number

201292

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2013-07-12

Regulatory Status

RX

2013
12 Jul
RX Application: 201292

Drug Name

GILOTRIF

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2013-07-12

201292 / 3

Active Ingredient

AFATINIB DIMALEATE

Application Number

201292

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2013-07-12

Regulatory Status

RX

2015
30 Jan
RX Application: 206073

Drug Name

GLYXAMBI

Product Number

1

Dosage Form

-

Strength

10MG;5MG

Approval Date

2015-01-30

206073 / 1

Active Ingredient

EMPAGLIFLOZIN; LINAGLIPTIN

Application Number

206073

Product Number

1

Dosage Form

-

Strength

10MG;5MG

Approval Date

2015-01-30

Regulatory Status

RX

2015
30 Jan
RX Application: 206073

Drug Name

GLYXAMBI

Product Number

2

Dosage Form

-

Strength

25MG;5MG

Approval Date

2015-01-30

206073 / 2

Active Ingredient

EMPAGLIFLOZIN; LINAGLIPTIN

Application Number

206073

Product Number

2

Dosage Form

-

Strength

25MG;5MG

Approval Date

2015-01-30

Regulatory Status

RX

2025
08 Aug
RX Application: 219042

Drug Name

HERNEXEOS

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2025-08-08

219042 / 1

Active Ingredient

ZONGERTINIB

Application Number

219042

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2025-08-08

Regulatory Status

RX

1990
13 Dec
Discontinued Application: 19817

Drug Name

IV PERSANTINE

Product Number

1

Dosage Form

-

Strength

5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1990-12-13

19817 / 1

Active Ingredient

DIPYRIDAMOLE

Application Number

19817

Product Number

1

Dosage Form

-

Strength

5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1990-12-13

Regulatory Status

Discontinued

2014
01 Aug
RX Application: 204629

Drug Name

JARDIANCE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2014-08-01

204629 / 1

Active Ingredient

EMPAGLIFLOZIN

Application Number

204629

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2014-08-01

Regulatory Status

RX

2014
01 Aug
RX Application: 204629

Drug Name

JARDIANCE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2014-08-01

204629 / 2

Active Ingredient

EMPAGLIFLOZIN

Application Number

204629

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2014-08-01

Regulatory Status

RX

2025
07 Oct
RX Application: 218764

Drug Name

JASCAYD

Product Number

1

Dosage Form

-

Strength

9MG

Approval Date

2025-10-07

218764 / 1

Active Ingredient

NERANDOMILAST

Application Number

218764

Product Number

1

Dosage Form

-

Strength

9MG

Approval Date

2025-10-07

Regulatory Status

RX

2025
07 Oct
RX Application: 218764

Drug Name

JASCAYD

Product Number

2

Dosage Form

-

Strength

18MG

Approval Date

2025-10-07

218764 / 2

Active Ingredient

NERANDOMILAST

Application Number

218764

Product Number

2

Dosage Form

-

Strength

18MG

Approval Date

2025-10-07

Regulatory Status

RX

-
Unclassified Application: 220449

Drug Name

JASCAYD

Product Number

1

Dosage Form

-

Strength

9MG

Approval Date

-

220449 / 1

Active Ingredient

NERANDOMILAST

Application Number

220449

Product Number

1

Dosage Form

-

Strength

9MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 220449

Drug Name

JASCAYD

Product Number

2

Dosage Form

-

Strength

18MG

Approval Date

-

220449 / 2

Active Ingredient

NERANDOMILAST

Application Number

220449

Product Number

2

Dosage Form

-

Strength

18MG

Approval Date

-

Regulatory Status

Unclassified

2012
30 Jan
RX Application: 201281

Drug Name

JENTADUETO

Product Number

1

Dosage Form

-

Strength

2.5MG;500MG

Approval Date

2012-01-30

201281 / 1

Active Ingredient

LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Application Number

201281

Product Number

1

Dosage Form

-

Strength

2.5MG;500MG

Approval Date

2012-01-30

Regulatory Status

RX

2012
30 Jan
RX Application: 201281

Drug Name

JENTADUETO

Product Number

2

Dosage Form

-

Strength

2.5MG;850MG

Approval Date

2012-01-30

201281 / 2

Active Ingredient

LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Application Number

201281

Product Number

2

Dosage Form

-

Strength

2.5MG;850MG

Approval Date

2012-01-30

Regulatory Status

RX

2012
30 Jan
RX Application: 201281

Drug Name

JENTADUETO

Product Number

3

Dosage Form

-

Strength

2.5MG;1GM

Approval Date

2012-01-30

201281 / 3

Active Ingredient

LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Application Number

201281

Product Number

3

Dosage Form

-

Strength

2.5MG;1GM

Approval Date

2012-01-30

Regulatory Status

RX

2016
27 May
RX Application: 208026

Drug Name

JENTADUETO XR

Product Number

1

Dosage Form

-

Strength

2.5MG;1GM

Approval Date

2016-05-27

208026 / 1

Active Ingredient

LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Application Number

208026

Product Number

1

Dosage Form

-

Strength

2.5MG;1GM

Approval Date

2016-05-27

Regulatory Status

RX

2016
27 May
RX Application: 208026

Drug Name

JENTADUETO XR

Product Number

2

Dosage Form

-

Strength

5MG;1GM

Approval Date

2016-05-27

208026 / 2

Active Ingredient

LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Application Number

208026

Product Number

2

Dosage Form

-

Strength

5MG;1GM

Approval Date

2016-05-27

Regulatory Status

RX

1985
30 Dec
Discontinued Application: 18873

Drug Name

MEXITIL

Product Number

2

Dosage Form

-

Strength

150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-12-30

18873 / 2

Active Ingredient

MEXILETINE HYDROCHLORIDE

Application Number

18873

Product Number

2

Dosage Form

-

Strength

150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-12-30

Regulatory Status

Discontinued

1985
30 Dec
Discontinued Application: 18873

Drug Name

MEXITIL

Product Number

3

Dosage Form

-

Strength

200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-12-30

18873 / 3

Active Ingredient

MEXILETINE HYDROCHLORIDE

Application Number

18873

Product Number

3

Dosage Form

-

Strength

200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-12-30

Regulatory Status

Discontinued

1985
30 Dec
Discontinued Application: 18873

Drug Name

MEXITIL

Product Number

4

Dosage Form

-

Strength

250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-12-30

18873 / 4

Active Ingredient

MEXILETINE HYDROCHLORIDE

Application Number

18873

Product Number

4

Dosage Form

-

Strength

250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1985-12-30

Regulatory Status

Discontinued

1998
10 Nov
Discontinued Application: 20850

Drug Name

MICARDIS

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1998-11-10

20850 / 1

Active Ingredient

TELMISARTAN

Application Number

20850

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1998-11-10

Regulatory Status

Discontinued

1998
10 Nov
Discontinued Application: 20850

Drug Name

MICARDIS

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1998-11-10

20850 / 2

Active Ingredient

TELMISARTAN

Application Number

20850

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1998-11-10

Regulatory Status

Discontinued

2000
04 Apr
Discontinued Application: 20850

Drug Name

MICARDIS

Product Number

3

Dosage Form

-

Strength

20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-04-04

20850 / 3

Active Ingredient

TELMISARTAN

Application Number

20850

Product Number

3

Dosage Form

-

Strength

20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-04-04

Regulatory Status

Discontinued

2000
17 Nov
RX Application: 21162

Drug Name

MICARDIS HCT

Product Number

1

Dosage Form

-

Strength

12.5MG;40MG

Approval Date

2000-11-17

21162 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; TELMISARTAN

Application Number

21162

Product Number

1

Dosage Form

-

Strength

12.5MG;40MG

Approval Date

2000-11-17

Regulatory Status

RX

2000
17 Nov
RX Application: 21162

Drug Name

MICARDIS HCT

Product Number

2

Dosage Form

-

Strength

12.5MG;80MG

Approval Date

2000-11-17

21162 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; TELMISARTAN

Application Number

21162

Product Number

2

Dosage Form

-

Strength

12.5MG;80MG

Approval Date

2000-11-17

Regulatory Status

RX

2004
19 Apr
RX Application: 21162

Drug Name

MICARDIS HCT

Product Number

3

Dosage Form

-

Strength

25MG;80MG

Approval Date

2004-04-19

21162 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; TELMISARTAN

Application Number

21162

Product Number

3

Dosage Form

-

Strength

25MG;80MG

Approval Date

2004-04-19

Regulatory Status

RX

1997
01 Jul
Discontinued Application: 20667

Drug Name

MIRAPEX

Product Number

1

Dosage Form

-

Strength

0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-07-01

20667 / 1

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

20667

Product Number

1

Dosage Form

-

Strength

0.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-07-01

Regulatory Status

Discontinued

1997
01 Jul
Discontinued Application: 20667

Drug Name

MIRAPEX

Product Number

2

Dosage Form

-

Strength

0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-07-01

20667 / 2

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

20667

Product Number

2

Dosage Form

-

Strength

0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-07-01

Regulatory Status

Discontinued

1997
01 Jul
Discontinued Application: 20667

Drug Name

MIRAPEX

Product Number

3

Dosage Form

-

Strength

1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-07-01

20667 / 3

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

20667

Product Number

3

Dosage Form

-

Strength

1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-07-01

Regulatory Status

Discontinued

1997
01 Jul
Discontinued Application: 20667

Drug Name

MIRAPEX

Product Number

4

Dosage Form

-

Strength

1.25MG

Approval Date

1997-07-01

20667 / 4

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

20667

Product Number

4

Dosage Form

-

Strength

1.25MG

Approval Date

1997-07-01

Regulatory Status

Discontinued

1997
01 Jul
Discontinued Application: 20667

Drug Name

MIRAPEX

Product Number

5

Dosage Form

-

Strength

1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-07-01

20667 / 5

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

20667

Product Number

5

Dosage Form

-

Strength

1.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-07-01

Regulatory Status

Discontinued

1998
12 Feb
Discontinued Application: 20667

Drug Name

MIRAPEX

Product Number

6

Dosage Form

-

Strength

0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1998-02-12

20667 / 6

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

20667

Product Number

6

Dosage Form

-

Strength

0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1998-02-12

Regulatory Status

Discontinued

2007
30 Jul
Discontinued Application: 20667

Drug Name

MIRAPEX

Product Number

7

Dosage Form

-

Strength

0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2007-07-30

20667 / 7

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

20667

Product Number

7

Dosage Form

-

Strength

0.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2007-07-30

Regulatory Status

Discontinued

2010
19 Feb
Discontinued Application: 22421

Drug Name

MIRAPEX ER

Product Number

1

Dosage Form

-

Strength

0.375MG

Approval Date

2010-02-19

22421 / 1

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

22421

Product Number

1

Dosage Form

-

Strength

0.375MG

Approval Date

2010-02-19

Regulatory Status

Discontinued

2010
19 Feb
Discontinued Application: 22421

Drug Name

MIRAPEX ER

Product Number

2

Dosage Form

-

Strength

0.75MG

Approval Date

2010-02-19

22421 / 2

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

22421

Product Number

2

Dosage Form

-

Strength

0.75MG

Approval Date

2010-02-19

Regulatory Status

Discontinued

2010
19 Feb
Discontinued Application: 22421

Drug Name

MIRAPEX ER

Product Number

3

Dosage Form

-

Strength

1.5MG

Approval Date

2010-02-19

22421 / 3

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

22421

Product Number

3

Dosage Form

-

Strength

1.5MG

Approval Date

2010-02-19

Regulatory Status

Discontinued

2010
19 Feb
Discontinued Application: 22421

Drug Name

MIRAPEX ER

Product Number

4

Dosage Form

-

Strength

3MG

Approval Date

2010-02-19

22421 / 4

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

22421

Product Number

4

Dosage Form

-

Strength

3MG

Approval Date

2010-02-19

Regulatory Status

Discontinued

2010
19 Feb
Discontinued Application: 22421

Drug Name

MIRAPEX ER

Product Number

5

Dosage Form

-

Strength

4.5MG

Approval Date

2010-02-19

22421 / 5

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

22421

Product Number

5

Dosage Form

-

Strength

4.5MG

Approval Date

2010-02-19

Regulatory Status

Discontinued

2011
17 Jun
Discontinued Application: 22421

Drug Name

MIRAPEX ER

Product Number

6

Dosage Form

-

Strength

2.25MG

Approval Date

2011-06-17

22421 / 6

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

22421

Product Number

6

Dosage Form

-

Strength

2.25MG

Approval Date

2011-06-17

Regulatory Status

Discontinued

2011
17 Jun
Discontinued Application: 22421

Drug Name

MIRAPEX ER

Product Number

7

Dosage Form

-

Strength

3.75MG

Approval Date

2011-06-17

22421 / 7

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

22421

Product Number

7

Dosage Form

-

Strength

3.75MG

Approval Date

2011-06-17

Regulatory Status

Discontinued

-
Unclassified Application: 22514

Drug Name

MIRAPEX ER

Product Number

1

Dosage Form

-

Strength

0.375MG

Approval Date

-

22514 / 1

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

22514

Product Number

1

Dosage Form

-

Strength

0.375MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 22514

Drug Name

MIRAPEX ER

Product Number

2

Dosage Form

-

Strength

0.75MG

Approval Date

-

22514 / 2

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

22514

Product Number

2

Dosage Form

-

Strength

0.75MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 22514

Drug Name

MIRAPEX ER

Product Number

3

Dosage Form

-

Strength

1.5MG

Approval Date

-

22514 / 3

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

22514

Product Number

3

Dosage Form

-

Strength

1.5MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 22514

Drug Name

MIRAPEX ER

Product Number

4

Dosage Form

-

Strength

3MG

Approval Date

-

22514 / 4

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

22514

Product Number

4

Dosage Form

-

Strength

3MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 22514

Drug Name

MIRAPEX ER

Product Number

5

Dosage Form

-

Strength

4.5MG

Approval Date

-

22514 / 5

Active Ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Application Number

22514

Product Number

5

Dosage Form

-

Strength

4.5MG

Approval Date

-

Regulatory Status

Unclassified

2000
13 Apr
Discontinued Application: 20938

Drug Name

MOBIC

Product Number

1

Dosage Form

-

Strength

7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-04-13

20938 / 1

Active Ingredient

MELOXICAM

Application Number

20938

Product Number

1

Dosage Form

-

Strength

7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-04-13

Regulatory Status

Discontinued

2000
23 Aug
Discontinued Application: 20938

Drug Name

MOBIC

Product Number

2

Dosage Form

-

Strength

15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-08-23

20938 / 2

Active Ingredient

MELOXICAM

Application Number

20938

Product Number

2

Dosage Form

-

Strength

15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-08-23

Regulatory Status

Discontinued

2014
15 Oct
RX Application: 205832

Drug Name

OFEV

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2014-10-15

205832 / 1

Active Ingredient

NINTEDANIB ESYLATE

Application Number

205832

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2014-10-15

Regulatory Status

RX

2014
15 Oct
RX Application: 205832

Drug Name

OFEV

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2014-10-15

205832 / 2

Active Ingredient

NINTEDANIB ESYLATE

Application Number

205832

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2014-10-15

Regulatory Status

RX

1986
22 Dec
Discontinued Application: 12836

Drug Name

PERSANTINE

Product Number

3

Dosage Form

-

Strength

25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1986-12-22

12836 / 3

Active Ingredient

DIPYRIDAMOLE

Application Number

12836

Product Number

3

Dosage Form

-

Strength

25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1986-12-22

Regulatory Status

Discontinued

1987
06 Feb
Discontinued Application: 12836

Drug Name

PERSANTINE

Product Number

4

Dosage Form

-

Strength

50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-02-06

12836 / 4

Active Ingredient

DIPYRIDAMOLE

Application Number

12836

Product Number

4

Dosage Form

-

Strength

50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-02-06

Regulatory Status

Discontinued

1987
06 Feb
Discontinued Application: 12836

Drug Name

PERSANTINE

Product Number

5

Dosage Form

-

Strength

75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-02-06

12836 / 5

Active Ingredient

DIPYRIDAMOLE

Application Number

12836

Product Number

5

Dosage Form

-

Strength

75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-02-06

Regulatory Status

Discontinued

2010
19 Oct
RX Application: 22512

Drug Name

PRADAXA

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2010-10-19

22512 / 1

Active Ingredient

DABIGATRAN ETEXILATE MESYLATE

Application Number

22512

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2010-10-19

Regulatory Status

RX

2010
19 Oct
RX Application: 22512

Drug Name

PRADAXA

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2010-10-19

22512 / 2

Active Ingredient

DABIGATRAN ETEXILATE MESYLATE

Application Number

22512

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2010-10-19

Regulatory Status

RX

2015
20 Nov
RX Application: 22512

Drug Name

PRADAXA

Product Number

3

Dosage Form

-

Strength

EQ 110MG BASE

Approval Date

2015-11-20

22512 / 3

Active Ingredient

DABIGATRAN ETEXILATE MESYLATE

Application Number

22512

Product Number

3

Dosage Form

-

Strength

EQ 110MG BASE

Approval Date

2015-11-20

Regulatory Status

RX

2021
21 Jun
RX Application: 214358

Drug Name

PRADAXA

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/PACKET

Approval Date

2021-06-21

214358 / 1

Active Ingredient

DABIGATRAN ETEXILATE MESYLATE

Application Number

214358

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/PACKET

Approval Date

2021-06-21

Regulatory Status

RX

2021
21 Jun
RX Application: 214358

Drug Name

PRADAXA

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE/PACKET

Approval Date

2021-06-21

214358 / 2

Active Ingredient

DABIGATRAN ETEXILATE MESYLATE

Application Number

214358

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE/PACKET

Approval Date

2021-06-21

Regulatory Status

RX

2021
21 Jun
RX Application: 214358

Drug Name

PRADAXA

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE/PACKET

Approval Date

2021-06-21

214358 / 3

Active Ingredient

DABIGATRAN ETEXILATE MESYLATE

Application Number

214358

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE/PACKET

Approval Date

2021-06-21

Regulatory Status

RX

2021
21 Jun
RX Application: 214358

Drug Name

PRADAXA

Product Number

4

Dosage Form

-

Strength

EQ 50MG BASE/PACKET

Approval Date

2021-06-21

214358 / 4

Active Ingredient

DABIGATRAN ETEXILATE MESYLATE

Application Number

214358

Product Number

4

Dosage Form

-

Strength

EQ 50MG BASE/PACKET

Approval Date

2021-06-21

Regulatory Status

RX

2021
21 Jun
RX Application: 214358

Drug Name

PRADAXA

Product Number

5

Dosage Form

-

Strength

EQ 110MG BASE/PACKET

Approval Date

2021-06-21

214358 / 5

Active Ingredient

DABIGATRAN ETEXILATE MESYLATE

Application Number

214358

Product Number

5

Dosage Form

-

Strength

EQ 110MG BASE/PACKET

Approval Date

2021-06-21

Regulatory Status

RX

2021
21 Jun
RX Application: 214358

Drug Name

PRADAXA

Product Number

6

Dosage Form

-

Strength

EQ 150MG BASE/PACKET

Approval Date

2021-06-21

214358 / 6

Active Ingredient

DABIGATRAN ETEXILATE MESYLATE

Application Number

214358

Product Number

6

Dosage Form

-

Strength

EQ 150MG BASE/PACKET

Approval Date

2021-06-21

Regulatory Status

RX

-
Unclassified Application: 761025

Drug Name

PRAXBIND

Product Number

1

Dosage Form

-

Strength

2.5G/50ML

Approval Date

-

761025 / 1

Active Ingredient

IDARUCIZUMAB

Application Number

761025

Product Number

1

Dosage Form

-

Strength

2.5G/50ML

Approval Date

-

Regulatory Status

Unclassified

1982
01 Jan
Discontinued Application: 10460

Drug Name

PRELUDIN

Product Number

5

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

10460 / 5

Active Ingredient

PHENMETRAZINE HYDROCHLORIDE

Application Number

10460

Product Number

5

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11752

Drug Name

PRELUDIN

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

1982-01-01

11752 / 3

Active Ingredient

PHENMETRAZINE HYDROCHLORIDE

Application Number

11752

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 11752

Drug Name

PRELUDIN

Product Number

4

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

11752 / 4

Active Ingredient

PHENMETRAZINE HYDROCHLORIDE

Application Number

11752

Product Number

4

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1997
29 Aug
Discontinued Application: 74662

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

1997-08-29

74662 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

74662

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

1997-08-29

Regulatory Status

Discontinued

1997
29 Aug
Discontinued Application: 74662

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

1997-08-29

74662 / 2

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

74662

Product Number

2

Dosage Form

-

Strength

EQ 300MG BASE

Approval Date

1997-08-29

Regulatory Status

Discontinued

2004
30 Jan
RX Application: 21395

Drug Name

SPIRIVA

Product Number

1

Dosage Form

-

Strength

EQ 0.018MG BASE/INH

Approval Date

2004-01-30

21395 / 1

Active Ingredient

TIOTROPIUM BROMIDE

Application Number

21395

Product Number

1

Dosage Form

-

Strength

EQ 0.018MG BASE/INH

Approval Date

2004-01-30

Regulatory Status

RX

2014
24 Sep
RX Application: 21936

Drug Name

SPIRIVA RESPIMAT

Product Number

1

Dosage Form

-

Strength

EQ 0.0025MG BASE/INH

Approval Date

2014-09-24

21936 / 1

Active Ingredient

TIOTROPIUM BROMIDE

Application Number

21936

Product Number

1

Dosage Form

-

Strength

EQ 0.0025MG BASE/INH

Approval Date

2014-09-24

Regulatory Status

RX

2015
15 Sep
RX Application: 21936

Drug Name

SPIRIVA RESPIMAT

Product Number

2

Dosage Form

-

Strength

EQ 0.00125MG BASE/INH

Approval Date

2015-09-15

21936 / 2

Active Ingredient

TIOTROPIUM BROMIDE

Application Number

21936

Product Number

2

Dosage Form

-

Strength

EQ 0.00125MG BASE/INH

Approval Date

2015-09-15

Regulatory Status

RX

-
Unclassified Application: 207070

Drug Name

SPIRIVA RESPIMAT

Product Number

1

Dosage Form

-

Strength

2.5MCG

Approval Date

-

207070 / 1

Active Ingredient

TIOTROPIUM BROMIDE

Application Number

207070

Product Number

1

Dosage Form

-

Strength

2.5MCG

Approval Date

-

Regulatory Status

Unclassified

2015
21 May
RX Application: 206756

Drug Name

STIOLTO RESPIMAT

Product Number

1

Dosage Form

-

Strength

EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH

Approval Date

2015-05-21

206756 / 1

Active Ingredient

OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE

Application Number

206756

Product Number

1

Dosage Form

-

Strength

EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH

Approval Date

2015-05-21

Regulatory Status

RX

2014
31 Jul
RX Application: 203108

Drug Name

STRIVERDI RESPIMAT

Product Number

1

Dosage Form

-

Strength

EQ 0.0025MG BASE/INH

Approval Date

2014-07-31

203108 / 1

Active Ingredient

OLODATEROL HYDROCHLORIDE

Application Number

203108

Product Number

1

Dosage Form

-

Strength

EQ 0.0025MG BASE/INH

Approval Date

2014-07-31

Regulatory Status

RX

2015
26 Aug
RX Application: 206111

Drug Name

SYNJARDY

Product Number

1

Dosage Form

-

Strength

5MG;500MG

Approval Date

2015-08-26

206111 / 1

Active Ingredient

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

206111

Product Number

1

Dosage Form

-

Strength

5MG;500MG

Approval Date

2015-08-26

Regulatory Status

RX

2015
26 Aug
RX Application: 206111

Drug Name

SYNJARDY

Product Number

2

Dosage Form

-

Strength

5MG;1GM

Approval Date

2015-08-26

206111 / 2

Active Ingredient

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

206111

Product Number

2

Dosage Form

-

Strength

5MG;1GM

Approval Date

2015-08-26

Regulatory Status

RX

2015
26 Aug
RX Application: 206111

Drug Name

SYNJARDY

Product Number

3

Dosage Form

-

Strength

12.5MG;500MG

Approval Date

2015-08-26

206111 / 3

Active Ingredient

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

206111

Product Number

3

Dosage Form

-

Strength

12.5MG;500MG

Approval Date

2015-08-26

Regulatory Status

RX

2015
26 Aug
RX Application: 206111

Drug Name

SYNJARDY

Product Number

4

Dosage Form

-

Strength

12.5MG;1GM

Approval Date

2015-08-26

206111 / 4

Active Ingredient

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

206111

Product Number

4

Dosage Form

-

Strength

12.5MG;1GM

Approval Date

2015-08-26

Regulatory Status

RX

2016
09 Dec
RX Application: 208658

Drug Name

SYNJARDY XR

Product Number

1

Dosage Form

-

Strength

5MG;1GM

Approval Date

2016-12-09

208658 / 1

Active Ingredient

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

208658

Product Number

1

Dosage Form

-

Strength

5MG;1GM

Approval Date

2016-12-09

Regulatory Status

RX

2016
09 Dec
RX Application: 208658

Drug Name

SYNJARDY XR

Product Number

2

Dosage Form

-

Strength

10MG;1GM

Approval Date

2016-12-09

208658 / 2

Active Ingredient

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

208658

Product Number

2

Dosage Form

-

Strength

10MG;1GM

Approval Date

2016-12-09

Regulatory Status

RX

2016
09 Dec
RX Application: 208658

Drug Name

SYNJARDY XR

Product Number

3

Dosage Form

-

Strength

12.5MG;1GM

Approval Date

2016-12-09

208658 / 3

Active Ingredient

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

208658

Product Number

3

Dosage Form

-

Strength

12.5MG;1GM

Approval Date

2016-12-09

Regulatory Status

RX

2016
09 Dec
RX Application: 208658

Drug Name

SYNJARDY XR

Product Number

4

Dosage Form

-

Strength

25MG;1GM

Approval Date

2016-12-09

208658 / 4

Active Ingredient

EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

208658

Product Number

4

Dosage Form

-

Strength

25MG;1GM

Approval Date

2016-12-09

Regulatory Status

RX

2011
02 May
RX Application: 201280

Drug Name

TRADJENTA

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-05-02

201280 / 1

Active Ingredient

LINAGLIPTIN

Application Number

201280

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-05-02

Regulatory Status

RX

2020
27 Jan
RX Application: 212614

Drug Name

TRIJARDY XR

Product Number

1

Dosage Form

-

Strength

5MG;2.5MG;1GM

Approval Date

2020-01-27

212614 / 1

Active Ingredient

EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Application Number

212614

Product Number

1

Dosage Form

-

Strength

5MG;2.5MG;1GM

Approval Date

2020-01-27

Regulatory Status

RX

2020
27 Jan
RX Application: 212614

Drug Name

TRIJARDY XR

Product Number

2

Dosage Form

-

Strength

10MG;5MG;1GM

Approval Date

2020-01-27

212614 / 2

Active Ingredient

EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Application Number

212614

Product Number

2

Dosage Form

-

Strength

10MG;5MG;1GM

Approval Date

2020-01-27

Regulatory Status

RX

2020
27 Jan
RX Application: 212614

Drug Name

TRIJARDY XR

Product Number

3

Dosage Form

-

Strength

12.5MG;2.5MG;1GM

Approval Date

2020-01-27

212614 / 3

Active Ingredient

EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Application Number

212614

Product Number

3

Dosage Form

-

Strength

12.5MG;2.5MG;1GM

Approval Date

2020-01-27

Regulatory Status

RX

2020
27 Jan
RX Application: 212614

Drug Name

TRIJARDY XR

Product Number

4

Dosage Form

-

Strength

25MG;5MG;1GM

Approval Date

2020-01-27

212614 / 4

Active Ingredient

EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Application Number

212614

Product Number

4

Dosage Form

-

Strength

25MG;5MG;1GM

Approval Date

2020-01-27

Regulatory Status

RX

2009
16 Oct
Discontinued Application: 22401

Drug Name

TWYNSTA

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2009-10-16

22401 / 1

Active Ingredient

AMLODIPINE BESYLATE; TELMISARTAN

Application Number

22401

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2009-10-16

Regulatory Status

Discontinued

2009
16 Oct
Discontinued Application: 22401

Drug Name

TWYNSTA

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2009-10-16

22401 / 2

Active Ingredient

AMLODIPINE BESYLATE; TELMISARTAN

Application Number

22401

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2009-10-16

Regulatory Status

Discontinued

2009
16 Oct
Discontinued Application: 22401

Drug Name

TWYNSTA

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2009-10-16

22401 / 3

Active Ingredient

AMLODIPINE BESYLATE; TELMISARTAN

Application Number

22401

Product Number

3

Dosage Form

-

Strength

EQ 5MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2009-10-16

Regulatory Status

Discontinued

2009
16 Oct
Discontinued Application: 22401

Drug Name

TWYNSTA

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2009-10-16

22401 / 4

Active Ingredient

AMLODIPINE BESYLATE; TELMISARTAN

Application Number

22401

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2009-10-16

Regulatory Status

Discontinued

1996
21 Jun
Discontinued Application: 20636

Drug Name

VIRAMUNE

Product Number

1

Dosage Form

-

Strength

200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-06-21

20636 / 1

Active Ingredient

NEVIRAPINE

Application Number

20636

Product Number

1

Dosage Form

-

Strength

200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-06-21

Regulatory Status

Discontinued

1998
11 Sep
Discontinued Application: 20933

Drug Name

VIRAMUNE

Product Number

1

Dosage Form

-

Strength

50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1998-09-11

20933 / 1

Active Ingredient

NEVIRAPINE

Application Number

20933

Product Number

1

Dosage Form

-

Strength

50MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1998-09-11

Regulatory Status

Discontinued

2011
25 Mar
Discontinued Application: 201152

Drug Name

VIRAMUNE XR

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2011-03-25

201152 / 1

Active Ingredient

NEVIRAPINE

Application Number

201152

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2011-03-25

Regulatory Status

Discontinued

2012
08 Nov
Discontinued Application: 201152

Drug Name

VIRAMUNE XR

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2012-11-08

201152 / 2

Active Ingredient

NEVIRAPINE

Application Number

201152

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2012-11-08

Regulatory Status

Discontinued

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Drug Status Breakdown
120 total
  • Discontinued
  • RX
  • Unclassified
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

AGGRENOX

Application Number

20884

Product Number

1

Active Ingredient

ASPIRIN; DIPYRIDAMOLE

Dosage Form

-

Strength

25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

FDA Approved Drug Data

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