Takeda Pharmaceutical
FDA Approved Drugs

Takeda Pharmaceutical

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 123
  • Latest Approval Date Feb 09, 2024
  • Data Source FDA
  • First Approval Date Dec 30, 1988
All
123
View
Unclassified
8
View
Discontinued
31
View
RX
84
View
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Company

Takeda Pharmaceutical

Country

Japan

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Company Snapshot

Takeda Pharmaceutical

1-1, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo 103-8668

Japan

www.takeda.com/ View on Map
FDA Approved Drug Records ( 123 records )
2005
29 Aug
Discontinued Application: 21842

Drug Name

ACTOPLUS MET

Product Number

1

Dosage Form

-

Strength

500MG;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-08-29

21842 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

Application Number

21842

Product Number

1

Dosage Form

-

Strength

500MG;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-08-29

Regulatory Status

Discontinued

2005
29 Aug
RX Application: 21842

Drug Name

ACTOPLUS MET

Product Number

2

Dosage Form

-

Strength

850MG;EQ 15MG BASE

Approval Date

2005-08-29

21842 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

Application Number

21842

Product Number

2

Dosage Form

-

Strength

850MG;EQ 15MG BASE

Approval Date

2005-08-29

Regulatory Status

RX

2009
12 May
Discontinued Application: 22024

Drug Name

ACTOPLUS MET XR

Product Number

1

Dosage Form

-

Strength

1GM;EQ 15MG BASE

Approval Date

2009-05-12

22024 / 1

Active Ingredient

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

Application Number

22024

Product Number

1

Dosage Form

-

Strength

1GM;EQ 15MG BASE

Approval Date

2009-05-12

Regulatory Status

Discontinued

2009
12 May
Discontinued Application: 22024

Drug Name

ACTOPLUS MET XR

Product Number

2

Dosage Form

-

Strength

1GM;EQ 30MG BASE

Approval Date

2009-05-12

22024 / 2

Active Ingredient

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

Application Number

22024

Product Number

2

Dosage Form

-

Strength

1GM;EQ 30MG BASE

Approval Date

2009-05-12

Regulatory Status

Discontinued

1999
15 Jul
RX Application: 21073

Drug Name

ACTOS

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

1999-07-15

21073 / 1

Active Ingredient

PIOGLITAZONE HYDROCHLORIDE

Application Number

21073

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

1999-07-15

Regulatory Status

RX

1999
15 Jul
RX Application: 21073

Drug Name

ACTOS

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

1999-07-15

21073 / 2

Active Ingredient

PIOGLITAZONE HYDROCHLORIDE

Application Number

21073

Product Number

2

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

1999-07-15

Regulatory Status

RX

1999
15 Jul
RX Application: 21073

Drug Name

ACTOS

Product Number

3

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

1999-07-15

21073 / 3

Active Ingredient

PIOGLITAZONE HYDROCHLORIDE

Application Number

21073

Product Number

3

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

1999-07-15

Regulatory Status

RX

2001
11 Oct
RX Application: 21303

Drug Name

ADDERALL XR 10

Product Number

1

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2001-10-11

21303 / 1

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

21303

Product Number

1

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2001-10-11

Regulatory Status

RX

2002
22 May
RX Application: 21303

Drug Name

ADDERALL XR 15

Product Number

6

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG

Approval Date

2002-05-22

21303 / 6

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

21303

Product Number

6

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG

Approval Date

2002-05-22

Regulatory Status

RX

2001
11 Oct
RX Application: 21303

Drug Name

ADDERALL XR 20

Product Number

2

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2001-10-11

21303 / 2

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

21303

Product Number

2

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2001-10-11

Regulatory Status

RX

2002
22 May
RX Application: 21303

Drug Name

ADDERALL XR 25

Product Number

4

Dosage Form

-

Strength

6.25MG;6.25MG;6.25MG;6.25MG

Approval Date

2002-05-22

21303 / 4

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

21303

Product Number

4

Dosage Form

-

Strength

6.25MG;6.25MG;6.25MG;6.25MG

Approval Date

2002-05-22

Regulatory Status

RX

2001
11 Oct
RX Application: 21303

Drug Name

ADDERALL XR 30

Product Number

3

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2001-10-11

21303 / 3

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

21303

Product Number

3

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2001-10-11

Regulatory Status

RX

2002
22 May
RX Application: 21303

Drug Name

ADDERALL XR 5

Product Number

5

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2002-05-22

21303 / 5

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

21303

Product Number

5

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2002-05-22

Regulatory Status

RX

1997
14 Mar
RX Application: 20333

Drug Name

AGRYLIN

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

1997-03-14

20333 / 1

Active Ingredient

ANAGRELIDE HYDROCHLORIDE

Application Number

20333

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

1997-03-14

Regulatory Status

RX

1997
14 Mar
Discontinued Application: 20333

Drug Name

AGRYLIN

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1997-03-14

20333 / 2

Active Ingredient

ANAGRELIDE HYDROCHLORIDE

Application Number

20333

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1997-03-14

Regulatory Status

Discontinued

2017
28 Apr
RX Application: 208772

Drug Name

ALUNBRIG

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2017-04-28

208772 / 1

Active Ingredient

BRIGATINIB

Application Number

208772

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2017-04-28

Regulatory Status

RX

2017
28 Apr
RX Application: 208772

Drug Name

ALUNBRIG

Product Number

2

Dosage Form

-

Strength

90MG

Approval Date

2017-04-28

208772 / 2

Active Ingredient

BRIGATINIB

Application Number

208772

Product Number

2

Dosage Form

-

Strength

90MG

Approval Date

2017-04-28

Regulatory Status

RX

2017
02 Oct
RX Application: 208772

Drug Name

ALUNBRIG

Product Number

3

Dosage Form

-

Strength

180MG

Approval Date

2017-10-02

208772 / 3

Active Ingredient

BRIGATINIB

Application Number

208772

Product Number

3

Dosage Form

-

Strength

180MG

Approval Date

2017-10-02

Regulatory Status

RX

1997
30 Sep
RX Application: 20712

Drug Name

CARBATROL

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1997-09-30

20712 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

20712

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1997-09-30

Regulatory Status

RX

1997
30 Sep
RX Application: 20712

Drug Name

CARBATROL

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1997-09-30

20712 / 2

Active Ingredient

CARBAMAZEPINE

Application Number

20712

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

1997-09-30

Regulatory Status

RX

1997
30 Sep
RX Application: 20712

Drug Name

CARBATROL

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

1997-09-30

20712 / 3

Active Ingredient

CARBAMAZEPINE

Application Number

20712

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

1997-09-30

Regulatory Status

RX

1988
30 Dec
Discontinued Application: 50601

Drug Name

CERADON

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1988-12-30

50601 / 1

Active Ingredient

CEFOTIAM HYDROCHLORIDE

Application Number

50601

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

1988-12-30

Regulatory Status

Discontinued

2009
29 Jul
Discontinued Application: 22352

Drug Name

COLCRYS

Product Number

1

Dosage Form

-

Strength

0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2009-07-29

22352 / 1

Active Ingredient

COLCHICINE

Application Number

22352

Product Number

1

Dosage Form

-

Strength

0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2009-07-29

Regulatory Status

Discontinued

2009
30 Jan
RX Application: 22287

Drug Name

DEXILANT

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2009-01-30

22287 / 1

Active Ingredient

DEXLANSOPRAZOLE

Application Number

22287

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2009-01-30

Regulatory Status

RX

2009
30 Jan
RX Application: 22287

Drug Name

DEXILANT

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

2009-01-30

22287 / 2

Active Ingredient

DEXLANSOPRAZOLE

Application Number

22287

Product Number

2

Dosage Form

-

Strength

60MG

Approval Date

2009-01-30

Regulatory Status

RX

2016
26 Jan
Discontinued Application: 208056

Drug Name

DEXILANT SOLUTAB

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2016-01-26

208056 / 1

Active Ingredient

DEXLANSOPRAZOLE

Application Number

208056

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2016-01-26

Regulatory Status

Discontinued

2006
28 Jul
RX Application: 21925

Drug Name

DUETACT

Product Number

1

Dosage Form

-

Strength

2MG;30MG

Approval Date

2006-07-28

21925 / 1

Active Ingredient

GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE

Application Number

21925

Product Number

1

Dosage Form

-

Strength

2MG;30MG

Approval Date

2006-07-28

Regulatory Status

RX

2006
28 Jul
RX Application: 21925

Drug Name

DUETACT

Product Number

2

Dosage Form

-

Strength

4MG;30MG

Approval Date

2006-07-28

21925 / 2

Active Ingredient

GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE

Application Number

21925

Product Number

2

Dosage Form

-

Strength

4MG;30MG

Approval Date

2006-07-28

Regulatory Status

RX

-
Unclassified Application: 125476

Drug Name

ENTYVIO

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

-

125476 / 1

Active Ingredient

VEDOLIZUMAB

Application Number

125476

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761133

Drug Name

ENTYVIO

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

-

761133 / 1

Active Ingredient

VEDOLIZUMAB

Application Number

761133

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761133

Drug Name

ENTYVIO

Product Number

2

Dosage Form

-

Strength

108MG/0.68ML

Approval Date

-

761133 / 2

Active Ingredient

VEDOLIZUMAB

Application Number

761133

Product Number

2

Dosage Form

-

Strength

108MG/0.68ML

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761359

Drug Name

ENTYVIO

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

-

761359 / 1

Active Ingredient

VEDOLIZUMAB

Application Number

761359

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 761359

Drug Name

ENTYVIO

Product Number

2

Dosage Form

-

Strength

108MG/0.68ML

Approval Date

-

761359 / 2

Active Ingredient

VEDOLIZUMAB

Application Number

761359

Product Number

2

Dosage Form

-

Strength

108MG/0.68ML

Approval Date

-

Regulatory Status

Unclassified

2024
09 Feb
RX Application: 213976

Drug Name

EOHILIA

Product Number

1

Dosage Form

-

Strength

2MG/10ML

Approval Date

2024-02-09

213976 / 1

Active Ingredient

BUDESONIDE

Application Number

213976

Product Number

1

Dosage Form

-

Strength

2MG/10ML

Approval Date

2024-02-09

Regulatory Status

RX

2021
15 Sep
Discontinued Application: 215310

Drug Name

EXKIVITY

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2021-09-15

215310 / 1

Active Ingredient

MOBOCERTINIB SUCCINATE

Application Number

215310

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2021-09-15

Regulatory Status

Discontinued

2011
25 Aug
RX Application: 22150

Drug Name

FIRAZYR

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date

2011-08-25

22150 / 1

Active Ingredient

ICATIBANT ACETATE

Application Number

22150

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date

2011-08-25

Regulatory Status

RX

2004
26 Oct
Discontinued Application: 21468

Drug Name

FOSRENOL

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2004-10-26

21468 / 1

Active Ingredient

LANTHANUM CARBONATE

Application Number

21468

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2004-10-26

Regulatory Status

Discontinued

2004
26 Oct
RX Application: 21468

Drug Name

FOSRENOL

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2004-10-26

21468 / 2

Active Ingredient

LANTHANUM CARBONATE

Application Number

21468

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE

Approval Date

2004-10-26

Regulatory Status

RX

2005
23 Nov
RX Application: 21468

Drug Name

FOSRENOL

Product Number

3

Dosage Form

-

Strength

EQ 750MG BASE

Approval Date

2005-11-23

21468 / 3

Active Ingredient

LANTHANUM CARBONATE

Application Number

21468

Product Number

3

Dosage Form

-

Strength

EQ 750MG BASE

Approval Date

2005-11-23

Regulatory Status

RX

2005
23 Nov
RX Application: 21468

Drug Name

FOSRENOL

Product Number

4

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

2005-11-23

21468 / 4

Active Ingredient

LANTHANUM CARBONATE

Application Number

21468

Product Number

4

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

2005-11-23

Regulatory Status

RX

2014
24 Sep
RX Application: 204734

Drug Name

FOSRENOL

Product Number

1

Dosage Form

-

Strength

EQ 750MG BASE

Approval Date

2014-09-24

204734 / 1

Active Ingredient

LANTHANUM CARBONATE

Application Number

204734

Product Number

1

Dosage Form

-

Strength

EQ 750MG BASE

Approval Date

2014-09-24

Regulatory Status

RX

2014
24 Sep
RX Application: 204734

Drug Name

FOSRENOL

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

2014-09-24

204734 / 2

Active Ingredient

LANTHANUM CARBONATE

Application Number

204734

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE

Approval Date

2014-09-24

Regulatory Status

RX

2023
08 Nov
RX Application: 217564

Drug Name

FRUZAQLA

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2023-11-08

217564 / 1

Active Ingredient

FRUQUINTINIB

Application Number

217564

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2023-11-08

Regulatory Status

RX

2023
08 Nov
RX Application: 217564

Drug Name

FRUZAQLA

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2023-11-08

217564 / 2

Active Ingredient

FRUQUINTINIB

Application Number

217564

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2023-11-08

Regulatory Status

RX

2012
21 Dec
RX Application: 203441

Drug Name

GATTEX KIT

Product Number

1

Dosage Form

-

Strength

5MG/VIAL

Approval Date

2012-12-21

203441 / 1

Active Ingredient

TEDUGLUTIDE

Application Number

203441

Product Number

1

Dosage Form

-

Strength

5MG/VIAL

Approval Date

2012-12-21

Regulatory Status

RX

2012
14 Dec
RX Application: 203469

Drug Name

ICLUSIG

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2012-12-14

203469 / 1

Active Ingredient

PONATINIB HYDROCHLORIDE

Application Number

203469

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2012-12-14

Regulatory Status

RX

2012
14 Dec
RX Application: 203469

Drug Name

ICLUSIG

Product Number

2

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2012-12-14

203469 / 2

Active Ingredient

PONATINIB HYDROCHLORIDE

Application Number

203469

Product Number

2

Dosage Form

-

Strength

EQ 45MG BASE

Approval Date

2012-12-14

Regulatory Status

RX

2015
23 Apr
RX Application: 203469

Drug Name

ICLUSIG

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2015-04-23

203469 / 3

Active Ingredient

PONATINIB HYDROCHLORIDE

Application Number

203469

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE

Approval Date

2015-04-23

Regulatory Status

RX

2020
18 Dec
RX Application: 203469

Drug Name

ICLUSIG

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2020-12-18

203469 / 4

Active Ingredient

PONATINIB HYDROCHLORIDE

Application Number

203469

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2020-12-18

Regulatory Status

RX

2009
02 Sep
RX Application: 22037

Drug Name

INTUNIV

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2009-09-02

22037 / 1

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

22037

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2009-09-02

Regulatory Status

RX

2009
02 Sep
RX Application: 22037

Drug Name

INTUNIV

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2009-09-02

22037 / 2

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

22037

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2009-09-02

Regulatory Status

RX

2009
02 Sep
RX Application: 22037

Drug Name

INTUNIV

Product Number

3

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2009-09-02

22037 / 3

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

22037

Product Number

3

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2009-09-02

Regulatory Status

RX

2009
02 Sep
RX Application: 22037

Drug Name

INTUNIV

Product Number

4

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2009-09-02

22037 / 4

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

22037

Product Number

4

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2009-09-02

Regulatory Status

RX

2013
25 Jan
RX Application: 203414

Drug Name

KAZANO

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE;500MG

Approval Date

2013-01-25

203414 / 1

Active Ingredient

ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE

Application Number

203414

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE;500MG

Approval Date

2013-01-25

Regulatory Status

RX

2013
25 Jan
RX Application: 203414

Drug Name

KAZANO

Product Number

2

Dosage Form

-

Strength

EQ 12.5MG BASE;1GM

Approval Date

2013-01-25

203414 / 2

Active Ingredient

ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE

Application Number

203414

Product Number

2

Dosage Form

-

Strength

EQ 12.5MG BASE;1GM

Approval Date

2013-01-25

Regulatory Status

RX

2007
16 Jan
RX Application: 22000

Drug Name

LIALDA

Product Number

1

Dosage Form

-

Strength

1.2GM

Approval Date

2007-01-16

22000 / 1

Active Ingredient

MESALAMINE

Application Number

22000

Product Number

1

Dosage Form

-

Strength

1.2GM

Approval Date

2007-01-16

Regulatory Status

RX

2021
23 Nov
RX Application: 215596

Drug Name

LIVTENCITY

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2021-11-23

215596 / 1

Active Ingredient

MARIBAVIR

Application Number

215596

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

2021-11-23

Regulatory Status

RX

2018
14 Dec
RX Application: 210166

Drug Name

MOTEGRITY

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2018-12-14

210166 / 1

Active Ingredient

PRUCALOPRIDE SUCCINATE

Application Number

210166

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2018-12-14

Regulatory Status

RX

2018
14 Dec
RX Application: 210166

Drug Name

MOTEGRITY

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2018-12-14

210166 / 2

Active Ingredient

PRUCALOPRIDE SUCCINATE

Application Number

210166

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2018-12-14

Regulatory Status

RX

2017
20 Jun
RX Application: 22063

Drug Name

MYDAYIS

Product Number

1

Dosage Form

-

Strength

3.125MG;3.125MG;3.125MG;3.125MG

Approval Date

2017-06-20

22063 / 1

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

22063

Product Number

1

Dosage Form

-

Strength

3.125MG;3.125MG;3.125MG;3.125MG

Approval Date

2017-06-20

Regulatory Status

RX

2017
20 Jun
RX Application: 22063

Drug Name

MYDAYIS

Product Number

2

Dosage Form

-

Strength

6.25MG;6.25MG;6.25MG;6.25MG

Approval Date

2017-06-20

22063 / 2

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

22063

Product Number

2

Dosage Form

-

Strength

6.25MG;6.25MG;6.25MG;6.25MG

Approval Date

2017-06-20

Regulatory Status

RX

2017
20 Jun
RX Application: 22063

Drug Name

MYDAYIS

Product Number

3

Dosage Form

-

Strength

9.375MG;9.375MG;9.375MG;9.375MG

Approval Date

2017-06-20

22063 / 3

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

22063

Product Number

3

Dosage Form

-

Strength

9.375MG;9.375MG;9.375MG;9.375MG

Approval Date

2017-06-20

Regulatory Status

RX

2017
20 Jun
RX Application: 22063

Drug Name

MYDAYIS

Product Number

4

Dosage Form

-

Strength

12.5MG;12.5MG;12.5MG;12.5MG

Approval Date

2017-06-20

22063 / 4

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

22063

Product Number

4

Dosage Form

-

Strength

12.5MG;12.5MG;12.5MG;12.5MG

Approval Date

2017-06-20

Regulatory Status

RX

2013
25 Jan
RX Application: 22271

Drug Name

NESINA

Product Number

1

Dosage Form

-

Strength

EQ 6.25MG BASE

Approval Date

2013-01-25

22271 / 1

Active Ingredient

ALOGLIPTIN BENZOATE

Application Number

22271

Product Number

1

Dosage Form

-

Strength

EQ 6.25MG BASE

Approval Date

2013-01-25

Regulatory Status

RX

2013
25 Jan
RX Application: 22271

Drug Name

NESINA

Product Number

2

Dosage Form

-

Strength

EQ 12.5MG BASE

Approval Date

2013-01-25

22271 / 2

Active Ingredient

ALOGLIPTIN BENZOATE

Application Number

22271

Product Number

2

Dosage Form

-

Strength

EQ 12.5MG BASE

Approval Date

2013-01-25

Regulatory Status

RX

2013
25 Jan
RX Application: 22271

Drug Name

NESINA

Product Number

3

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2013-01-25

22271 / 3

Active Ingredient

ALOGLIPTIN BENZOATE

Application Number

22271

Product Number

3

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2013-01-25

Regulatory Status

RX

2015
20 Nov
RX Application: 208462

Drug Name

NINLARO

Product Number

1

Dosage Form

-

Strength

EQ 2.3MG BASE

Approval Date

2015-11-20

208462 / 1

Active Ingredient

IXAZOMIB CITRATE

Application Number

208462

Product Number

1

Dosage Form

-

Strength

EQ 2.3MG BASE

Approval Date

2015-11-20

Regulatory Status

RX

2015
20 Nov
RX Application: 208462

Drug Name

NINLARO

Product Number

2

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2015-11-20

208462 / 2

Active Ingredient

IXAZOMIB CITRATE

Application Number

208462

Product Number

2

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2015-11-20

Regulatory Status

RX

2015
20 Nov
RX Application: 208462

Drug Name

NINLARO

Product Number

3

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2015-11-20

208462 / 3

Active Ingredient

IXAZOMIB CITRATE

Application Number

208462

Product Number

3

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2015-11-20

Regulatory Status

RX

2012
27 Mar
Discontinued Application: 202799

Drug Name

OMONTYS

Product Number

7

Dosage Form

-

Strength

EQ 10MG BASE/ML (EQ 10MG BASE/ML)

Approval Date

2012-03-27

202799 / 7

Active Ingredient

PEGINESATIDE ACETATE

Application Number

202799

Product Number

7

Dosage Form

-

Strength

EQ 10MG BASE/ML (EQ 10MG BASE/ML)

Approval Date

2012-03-27

Regulatory Status

Discontinued

2012
27 Mar
Discontinued Application: 202799

Drug Name

OMONTYS

Product Number

8

Dosage Form

-

Strength

EQ 20MG BASE/2ML (EQ 10MG BASE/ML)

Approval Date

2012-03-27

202799 / 8

Active Ingredient

PEGINESATIDE ACETATE

Application Number

202799

Product Number

8

Dosage Form

-

Strength

EQ 20MG BASE/2ML (EQ 10MG BASE/ML)

Approval Date

2012-03-27

Regulatory Status

Discontinued

2012
27 Mar
Discontinued Application: 202799

Drug Name

OMONTYS PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML)

Approval Date

2012-03-27

202799 / 1

Active Ingredient

PEGINESATIDE ACETATE

Application Number

202799

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML)

Approval Date

2012-03-27

Regulatory Status

Discontinued

2012
27 Mar
Discontinued Application: 202799

Drug Name

OMONTYS PRESERVATIVE FREE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML)

Approval Date

2012-03-27

202799 / 2

Active Ingredient

PEGINESATIDE ACETATE

Application Number

202799

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML)

Approval Date

2012-03-27

Regulatory Status

Discontinued

2012
27 Mar
Discontinued Application: 202799

Drug Name

OMONTYS PRESERVATIVE FREE

Product Number

3

Dosage Form

-

Strength

EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)

Approval Date

2012-03-27

202799 / 3

Active Ingredient

PEGINESATIDE ACETATE

Application Number

202799

Product Number

3

Dosage Form

-

Strength

EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)

Approval Date

2012-03-27

Regulatory Status

Discontinued

2012
27 Mar
Discontinued Application: 202799

Drug Name

OMONTYS PRESERVATIVE FREE

Product Number

4

Dosage Form

-

Strength

EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML)

Approval Date

2012-03-27

202799 / 4

Active Ingredient

PEGINESATIDE ACETATE

Application Number

202799

Product Number

4

Dosage Form

-

Strength

EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML)

Approval Date

2012-03-27

Regulatory Status

Discontinued

2012
27 Mar
Discontinued Application: 202799

Drug Name

OMONTYS PRESERVATIVE FREE

Product Number

5

Dosage Form

-

Strength

EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML)

Approval Date

2012-03-27

202799 / 5

Active Ingredient

PEGINESATIDE ACETATE

Application Number

202799

Product Number

5

Dosage Form

-

Strength

EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML)

Approval Date

2012-03-27

Regulatory Status

Discontinued

2012
27 Mar
Discontinued Application: 202799

Drug Name

OMONTYS PRESERVATIVE FREE

Product Number

6

Dosage Form

-

Strength

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

Approval Date

2012-03-27

202799 / 6

Active Ingredient

PEGINESATIDE ACETATE

Application Number

202799

Product Number

6

Dosage Form

-

Strength

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

Approval Date

2012-03-27

Regulatory Status

Discontinued

-
Unclassified Application: 220860

Drug Name

ORZEYFUL

Product Number

1

Dosage Form

-

Strength

.05MG

Approval Date

-

220860 / 1

Active Ingredient

OVEPOREXTON

Application Number

220860

Product Number

1

Dosage Form

-

Strength

.05MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 220860

Drug Name

ORZEYFUL

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

-

220860 / 2

Active Ingredient

OVEPOREXTON

Application Number

220860

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 220860

Drug Name

ORZEYFUL

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

-

220860 / 3

Active Ingredient

OVEPOREXTON

Application Number

220860

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

-

Regulatory Status

Unclassified

2013
25 Jan
RX Application: 22426

Drug Name

OSENI

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE;EQ 15MG BASE

Approval Date

2013-01-25

22426 / 1

Active Ingredient

ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE

Application Number

22426

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE;EQ 15MG BASE

Approval Date

2013-01-25

Regulatory Status

RX

2013
25 Jan
RX Application: 22426

Drug Name

OSENI

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE;EQ 30MG BASE

Approval Date

2013-01-25

22426 / 2

Active Ingredient

ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE

Application Number

22426

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE;EQ 30MG BASE

Approval Date

2013-01-25

Regulatory Status

RX

2013
25 Jan
RX Application: 22426

Drug Name

OSENI

Product Number

3

Dosage Form

-

Strength

EQ 25MG BASE;EQ 45MG BASE

Approval Date

2013-01-25

22426 / 3

Active Ingredient

ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE

Application Number

22426

Product Number

3

Dosage Form

-

Strength

EQ 25MG BASE;EQ 45MG BASE

Approval Date

2013-01-25

Regulatory Status

RX

2013
25 Jan
Discontinued Application: 22426

Drug Name

OSENI

Product Number

4

Dosage Form

-

Strength

EQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2013-01-25

22426 / 4

Active Ingredient

ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE

Application Number

22426

Product Number

4

Dosage Form

-

Strength

EQ 12.5MG BASE;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2013-01-25

Regulatory Status

Discontinued

2013
25 Jan
RX Application: 22426

Drug Name

OSENI

Product Number

5

Dosage Form

-

Strength

EQ 12.5MG BASE;EQ 30MG BASE

Approval Date

2013-01-25

22426 / 5

Active Ingredient

ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE

Application Number

22426

Product Number

5

Dosage Form

-

Strength

EQ 12.5MG BASE;EQ 30MG BASE

Approval Date

2013-01-25

Regulatory Status

RX

2013
25 Jan
Discontinued Application: 22426

Drug Name

OSENI

Product Number

6

Dosage Form

-

Strength

EQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2013-01-25

22426 / 6

Active Ingredient

ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE

Application Number

22426

Product Number

6

Dosage Form

-

Strength

EQ 12.5MG BASE;EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2013-01-25

Regulatory Status

Discontinued

1993
10 May
RX Application: 20049

Drug Name

PENTASA

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1993-05-10

20049 / 1

Active Ingredient

MESALAMINE

Application Number

20049

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1993-05-10

Regulatory Status

RX

2004
08 Jul
RX Application: 20049

Drug Name

PENTASA

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2004-07-08

20049 / 2

Active Ingredient

MESALAMINE

Application Number

20049

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2004-07-08

Regulatory Status

RX

1995
10 May
Discontinued Application: 20406

Drug Name

PREVACID

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1995-05-10

20406 / 1

Active Ingredient

LANSOPRAZOLE

Application Number

20406

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1995-05-10

Regulatory Status

Discontinued

1995
10 May
RX Application: 20406

Drug Name

PREVACID

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

1995-05-10

20406 / 2

Active Ingredient

LANSOPRAZOLE

Application Number

20406

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

1995-05-10

Regulatory Status

RX

2001
03 May
Discontinued Application: 21281

Drug Name

PREVACID

Product Number

1

Dosage Form

-

Strength

15MG/PACKET

Approval Date

2001-05-03

21281 / 1

Active Ingredient

LANSOPRAZOLE

Application Number

21281

Product Number

1

Dosage Form

-

Strength

15MG/PACKET

Approval Date

2001-05-03

Regulatory Status

Discontinued

2001
03 May
Discontinued Application: 21281

Drug Name

PREVACID

Product Number

2

Dosage Form

-

Strength

30MG/PACKET

Approval Date

2001-05-03

21281 / 2

Active Ingredient

LANSOPRAZOLE

Application Number

21281

Product Number

2

Dosage Form

-

Strength

30MG/PACKET

Approval Date

2001-05-03

Regulatory Status

Discontinued

2002
30 Aug
RX Application: 21428

Drug Name

PREVACID

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2002-08-30

21428 / 1

Active Ingredient

LANSOPRAZOLE

Application Number

21428

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2002-08-30

Regulatory Status

RX

2002
30 Aug
RX Application: 21428

Drug Name

PREVACID

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2002-08-30

21428 / 2

Active Ingredient

LANSOPRAZOLE

Application Number

21428

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2002-08-30

Regulatory Status

RX

2004
27 May
Discontinued Application: 21566

Drug Name

PREVACID IV

Product Number

1

Dosage Form

-

Strength

30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2004-05-27

21566 / 1

Active Ingredient

LANSOPRAZOLE

Application Number

21566

Product Number

1

Dosage Form

-

Strength

30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2004-05-27

Regulatory Status

Discontinued

2003
14 Nov
Discontinued Application: 21507

Drug Name

PREVACID NAPRAPAC 250 (COPACKAGED)

Product Number

2

Dosage Form

-

Strength

15MG,N/A;N/A,250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-11-14

21507 / 2

Active Ingredient

LANSOPRAZOLE; NAPROXEN

Application Number

21507

Product Number

2

Dosage Form

-

Strength

15MG,N/A;N/A,250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-11-14

Regulatory Status

Discontinued

2003
14 Nov
Discontinued Application: 21507

Drug Name

PREVACID NAPRAPAC 375 (COPACKAGED)

Product Number

3

Dosage Form

-

Strength

15MG,N/A;N/A,375MG

Approval Date

2003-11-14

21507 / 3

Active Ingredient

LANSOPRAZOLE; NAPROXEN

Application Number

21507

Product Number

3

Dosage Form

-

Strength

15MG,N/A;N/A,375MG

Approval Date

2003-11-14

Regulatory Status

Discontinued

2003
14 Nov
Discontinued Application: 21507

Drug Name

PREVACID NAPRAPAC 500 (COPACKAGED)

Product Number

4

Dosage Form

-

Strength

15MG,N/A;N/A,500MG

Approval Date

2003-11-14

21507 / 4

Active Ingredient

LANSOPRAZOLE; NAPROXEN

Application Number

21507

Product Number

4

Dosage Form

-

Strength

15MG,N/A;N/A,500MG

Approval Date

2003-11-14

Regulatory Status

Discontinued

1997
02 Dec
Discontinued Application: 50757

Drug Name

PREVPAC (COPACKAGED)

Product Number

1

Dosage Form

-

Strength

500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-12-02

50757 / 1

Active Ingredient

AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE

Application Number

50757

Product Number

1

Dosage Form

-

Strength

500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-12-02

Regulatory Status

Discontinued

1996
06 Sep
Discontinued Application: 19815

Drug Name

PROAMATINE

Product Number

1

Dosage Form

-

Strength

2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-09-06

19815 / 1

Active Ingredient

MIDODRINE HYDROCHLORIDE

Application Number

19815

Product Number

1

Dosage Form

-

Strength

2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-09-06

Regulatory Status

Discontinued

1996
06 Sep
Discontinued Application: 19815

Drug Name

PROAMATINE

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1996-09-06

19815 / 2

Active Ingredient

MIDODRINE HYDROCHLORIDE

Application Number

19815

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1996-09-06

Regulatory Status

Discontinued

2002
20 Mar
Discontinued Application: 19815

Drug Name

PROAMATINE

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2002-03-20

19815 / 3

Active Ingredient

MIDODRINE HYDROCHLORIDE

Application Number

19815

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2002-03-20

Regulatory Status

Discontinued

2005
22 Jul
RX Application: 21782

Drug Name

ROZEREM

Product Number

1

Dosage Form

-

Strength

8MG

Approval Date

2005-07-22

21782 / 1

Active Ingredient

RAMELTEON

Application Number

21782

Product Number

1

Dosage Form

-

Strength

8MG

Approval Date

2005-07-22

Regulatory Status

RX

2013
30 Sep
RX Application: 204447

Drug Name

TRINTELLIX

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2013-09-30

204447 / 1

Active Ingredient

VORTIOXETINE HYDROBROMIDE

Application Number

204447

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2013-09-30

Regulatory Status

RX

2013
30 Sep
RX Application: 204447

Drug Name

TRINTELLIX

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2013-09-30

204447 / 2

Active Ingredient

VORTIOXETINE HYDROBROMIDE

Application Number

204447

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2013-09-30

Regulatory Status

RX

2013
30 Sep
Discontinued Application: 204447

Drug Name

TRINTELLIX

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2013-09-30

204447 / 3

Active Ingredient

VORTIOXETINE HYDROBROMIDE

Application Number

204447

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2013-09-30

Regulatory Status

Discontinued

2013
30 Sep
RX Application: 204447

Drug Name

TRINTELLIX

Product Number

4

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2013-09-30

204447 / 4

Active Ingredient

VORTIOXETINE HYDROBROMIDE

Application Number

204447

Product Number

4

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2013-09-30

Regulatory Status

RX

2009
13 Feb
RX Application: 21856

Drug Name

ULORIC

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2009-02-13

21856 / 1

Active Ingredient

FEBUXOSTAT

Application Number

21856

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2009-02-13

Regulatory Status

RX

2009
13 Feb
RX Application: 21856

Drug Name

ULORIC

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2009-02-13

21856 / 2

Active Ingredient

FEBUXOSTAT

Application Number

21856

Product Number

2

Dosage Form

-

Strength

80MG

Approval Date

2009-02-13

Regulatory Status

RX

2003
13 May
RX Application: 21602

Drug Name

VELCADE

Product Number

1

Dosage Form

-

Strength

3.5MG/VIAL

Approval Date

2003-05-13

21602 / 1

Active Ingredient

BORTEZOMIB

Application Number

21602

Product Number

1

Dosage Form

-

Strength

3.5MG/VIAL

Approval Date

2003-05-13

Regulatory Status

RX

2007
23 Feb
RX Application: 21977

Drug Name

VYVANSE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2007-02-23

21977 / 1

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

21977

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2007-02-23

Regulatory Status

RX

2007
23 Feb
RX Application: 21977

Drug Name

VYVANSE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2007-02-23

21977 / 2

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

21977

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2007-02-23

Regulatory Status

RX

2007
23 Feb
RX Application: 21977

Drug Name

VYVANSE

Product Number

3

Dosage Form

-

Strength

70MG

Approval Date

2007-02-23

21977 / 3

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

21977

Product Number

3

Dosage Form

-

Strength

70MG

Approval Date

2007-02-23

Regulatory Status

RX

2007
10 Dec
RX Application: 21977

Drug Name

VYVANSE

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2007-12-10

21977 / 4

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

21977

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2007-12-10

Regulatory Status

RX

2007
10 Dec
RX Application: 21977

Drug Name

VYVANSE

Product Number

5

Dosage Form

-

Strength

40MG

Approval Date

2007-12-10

21977 / 5

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

21977

Product Number

5

Dosage Form

-

Strength

40MG

Approval Date

2007-12-10

Regulatory Status

RX

2007
10 Dec
RX Application: 21977

Drug Name

VYVANSE

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2007-12-10

21977 / 6

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

21977

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2007-12-10

Regulatory Status

RX

2014
30 Oct
RX Application: 21977

Drug Name

VYVANSE

Product Number

7

Dosage Form

-

Strength

10MG

Approval Date

2014-10-30

21977 / 7

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

21977

Product Number

7

Dosage Form

-

Strength

10MG

Approval Date

2014-10-30

Regulatory Status

RX

2017
28 Jan
RX Application: 208510

Drug Name

VYVANSE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2017-01-28

208510 / 1

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

208510

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2017-01-28

Regulatory Status

RX

2017
28 Jan
RX Application: 208510

Drug Name

VYVANSE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2017-01-28

208510 / 2

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

208510

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2017-01-28

Regulatory Status

RX

2017
28 Jan
RX Application: 208510

Drug Name

VYVANSE

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2017-01-28

208510 / 3

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

208510

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2017-01-28

Regulatory Status

RX

2017
28 Jan
RX Application: 208510

Drug Name

VYVANSE

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2017-01-28

208510 / 4

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

208510

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2017-01-28

Regulatory Status

RX

2017
28 Jan
RX Application: 208510

Drug Name

VYVANSE

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2017-01-28

208510 / 5

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

208510

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2017-01-28

Regulatory Status

RX

2017
28 Jan
RX Application: 208510

Drug Name

VYVANSE

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2017-01-28

208510 / 6

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

208510

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2017-01-28

Regulatory Status

RX

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Drug Status Breakdown
123 total
  • Discontinued
  • RX
  • Unclassified
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

ACTOPLUS MET

Application Number

21842

Product Number

1

Active Ingredient

METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE

Dosage Form

-

Strength

500MG;EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

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Organized FDA drug records

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