Boehringer Ingelheim GmbH RX
FDA Approved Drugs

Boehringer Ingelheim GmbH 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 50
  • Latest Approval Date Oct 07, 2025
  • Data Source FDA
  • First Approval Date Nov 17, 2000
All
120
View
Unclassified
11
View
Discontinued
59
View
RX
50
View
Company Overview

Company

Boehringer Ingelheim GmbH RX

Country

Germany

Website

Visit Website

Email

info@boehringer-ingelheim.de

Social Profiles

LinkedIn X / Twitter
Company Snapshot

Boehringer Ingelheim GmbH RX

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 ( 50 records )
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

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

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

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

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

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

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

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

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

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

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

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Drug Status Breakdown
50 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

APTIVUS

Application Number

21814

Product Number

1

Active Ingredient

TIPRANAVIR

Dosage Form

-

Strength

250MG

FDA Approved Drug Data

Approved drug product information

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Structured Database

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