Novartis Pharmaceuticals Corporation RX
FDA Approved Drugs

Novartis Pharmaceuticals Corporation 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 121
  • Latest Approval Date Sep 30, 2025
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
369
View
Unclassified
31
View
Discontinued
217
View
RX
121
View
Company Overview

Company

Novartis Pharmaceuticals Corporation RX

Country

Switzerland

Website

Visit Website

Email

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Company Snapshot

Novartis Pharmaceuticals Corporation RX

Klybeckstrasse 141, CH-4057, Basel

Switzerland

www.novartis.com/ View on Map
FDA Approved Drug Records ( 121 records )
2009
30 Mar
RX Application: 22334

Drug Name

AFINITOR

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2009-03-30

22334 / 1

Active Ingredient

EVEROLIMUS

Application Number

22334

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2009-03-30

Regulatory Status

RX

2009
30 Mar
RX Application: 22334

Drug Name

AFINITOR

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2009-03-30

22334 / 2

Active Ingredient

EVEROLIMUS

Application Number

22334

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2009-03-30

Regulatory Status

RX

2010
09 Jul
RX Application: 22334

Drug Name

AFINITOR

Product Number

3

Dosage Form

-

Strength

2.5MG

Approval Date

2010-07-09

22334 / 3

Active Ingredient

EVEROLIMUS

Application Number

22334

Product Number

3

Dosage Form

-

Strength

2.5MG

Approval Date

2010-07-09

Regulatory Status

RX

2012
30 Mar
RX Application: 22334

Drug Name

AFINITOR

Product Number

4

Dosage Form

-

Strength

7.5MG

Approval Date

2012-03-30

22334 / 4

Active Ingredient

EVEROLIMUS

Application Number

22334

Product Number

4

Dosage Form

-

Strength

7.5MG

Approval Date

2012-03-30

Regulatory Status

RX

2012
29 Aug
RX Application: 203985

Drug Name

AFINITOR DISPERZ

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2012-08-29

203985 / 1

Active Ingredient

EVEROLIMUS

Application Number

203985

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2012-08-29

Regulatory Status

RX

2012
29 Aug
RX Application: 203985

Drug Name

AFINITOR DISPERZ

Product Number

2

Dosage Form

-

Strength

3MG

Approval Date

2012-08-29

203985 / 2

Active Ingredient

EVEROLIMUS

Application Number

203985

Product Number

2

Dosage Form

-

Strength

3MG

Approval Date

2012-08-29

Regulatory Status

RX

2012
29 Aug
RX Application: 203985

Drug Name

AFINITOR DISPERZ

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2012-08-29

203985 / 3

Active Ingredient

EVEROLIMUS

Application Number

203985

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2012-08-29

Regulatory Status

RX

1989
29 Dec
RX Application: 19845

Drug Name

BETOPTIC S

Product Number

1

Dosage Form

-

Strength

EQ 0.25% BASE

Approval Date

1989-12-29

19845 / 1

Active Ingredient

BETAXOLOL HYDROCHLORIDE

Application Number

19845

Product Number

1

Dosage Form

-

Strength

EQ 0.25% BASE

Approval Date

1989-12-29

Regulatory Status

RX

2009
07 Apr
RX Application: 22268

Drug Name

COARTEM

Product Number

1

Dosage Form

-

Strength

20MG;120MG

Approval Date

2009-04-07

22268 / 1

Active Ingredient

ARTEMETHER; LUMEFANTRINE

Application Number

22268

Product Number

1

Dosage Form

-

Strength

20MG;120MG

Approval Date

2009-04-07

Regulatory Status

RX

2001
18 Jul
RX Application: 21283

Drug Name

DIOVAN

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

2001-07-18

21283 / 1

Active Ingredient

VALSARTAN

Application Number

21283

Product Number

1

Dosage Form

-

Strength

80MG

Approval Date

2001-07-18

Regulatory Status

RX

2001
18 Jul
RX Application: 21283

Drug Name

DIOVAN

Product Number

2

Dosage Form

-

Strength

160MG

Approval Date

2001-07-18

21283 / 2

Active Ingredient

VALSARTAN

Application Number

21283

Product Number

2

Dosage Form

-

Strength

160MG

Approval Date

2001-07-18

Regulatory Status

RX

2001
18 Jul
RX Application: 21283

Drug Name

DIOVAN

Product Number

3

Dosage Form

-

Strength

320MG

Approval Date

2001-07-18

21283 / 3

Active Ingredient

VALSARTAN

Application Number

21283

Product Number

3

Dosage Form

-

Strength

320MG

Approval Date

2001-07-18

Regulatory Status

RX

2002
14 Aug
RX Application: 21283

Drug Name

DIOVAN

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2002-08-14

21283 / 4

Active Ingredient

VALSARTAN

Application Number

21283

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2002-08-14

Regulatory Status

RX

1998
06 Mar
RX Application: 20818

Drug Name

DIOVAN HCT

Product Number

1

Dosage Form

-

Strength

12.5MG;80MG

Approval Date

1998-03-06

20818 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

20818

Product Number

1

Dosage Form

-

Strength

12.5MG;80MG

Approval Date

1998-03-06

Regulatory Status

RX

1998
06 Mar
RX Application: 20818

Drug Name

DIOVAN HCT

Product Number

2

Dosage Form

-

Strength

12.5MG;160MG

Approval Date

1998-03-06

20818 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

20818

Product Number

2

Dosage Form

-

Strength

12.5MG;160MG

Approval Date

1998-03-06

Regulatory Status

RX

2002
17 Jan
RX Application: 20818

Drug Name

DIOVAN HCT

Product Number

3

Dosage Form

-

Strength

25MG;160MG

Approval Date

2002-01-17

20818 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

20818

Product Number

3

Dosage Form

-

Strength

25MG;160MG

Approval Date

2002-01-17

Regulatory Status

RX

2006
28 Apr
RX Application: 20818

Drug Name

DIOVAN HCT

Product Number

4

Dosage Form

-

Strength

12.5MG;320MG

Approval Date

2006-04-28

20818 / 4

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

20818

Product Number

4

Dosage Form

-

Strength

12.5MG;320MG

Approval Date

2006-04-28

Regulatory Status

RX

2006
28 Apr
RX Application: 20818

Drug Name

DIOVAN HCT

Product Number

5

Dosage Form

-

Strength

25MG;320MG

Approval Date

2006-04-28

20818 / 5

Active Ingredient

HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

20818

Product Number

5

Dosage Form

-

Strength

25MG;320MG

Approval Date

2006-04-28

Regulatory Status

RX

2019
13 Feb
RX Application: 208711

Drug Name

EGATEN

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2019-02-13

208711 / 1

Active Ingredient

TRICLABENDAZOLE

Application Number

208711

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2019-02-13

Regulatory Status

RX

2015
07 Jul
RX Application: 207620

Drug Name

ENTRESTO

Product Number

1

Dosage Form

-

Strength

24MG;26MG

Approval Date

2015-07-07

207620 / 1

Active Ingredient

SACUBITRIL; VALSARTAN

Application Number

207620

Product Number

1

Dosage Form

-

Strength

24MG;26MG

Approval Date

2015-07-07

Regulatory Status

RX

2015
07 Jul
RX Application: 207620

Drug Name

ENTRESTO

Product Number

2

Dosage Form

-

Strength

49MG;51MG

Approval Date

2015-07-07

207620 / 2

Active Ingredient

SACUBITRIL; VALSARTAN

Application Number

207620

Product Number

2

Dosage Form

-

Strength

49MG;51MG

Approval Date

2015-07-07

Regulatory Status

RX

2015
07 Jul
RX Application: 207620

Drug Name

ENTRESTO

Product Number

3

Dosage Form

-

Strength

97MG;103MG

Approval Date

2015-07-07

207620 / 3

Active Ingredient

SACUBITRIL; VALSARTAN

Application Number

207620

Product Number

3

Dosage Form

-

Strength

97MG;103MG

Approval Date

2015-07-07

Regulatory Status

RX

2024
12 Apr
RX Application: 218591

Drug Name

ENTRESTO SPRINKLE

Product Number

1

Dosage Form

-

Strength

6MG;6MG

Approval Date

2024-04-12

218591 / 1

Active Ingredient

SACUBITRIL; VALSARTAN

Application Number

218591

Product Number

1

Dosage Form

-

Strength

6MG;6MG

Approval Date

2024-04-12

Regulatory Status

RX

2024
12 Apr
RX Application: 218591

Drug Name

ENTRESTO SPRINKLE

Product Number

2

Dosage Form

-

Strength

15MG;16MG

Approval Date

2024-04-12

218591 / 2

Active Ingredient

SACUBITRIL; VALSARTAN

Application Number

218591

Product Number

2

Dosage Form

-

Strength

15MG;16MG

Approval Date

2024-04-12

Regulatory Status

RX

2007
20 Jun
RX Application: 21990

Drug Name

EXFORGE

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;160MG

Approval Date

2007-06-20

21990 / 2

Active Ingredient

AMLODIPINE BESYLATE; VALSARTAN

Application Number

21990

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;160MG

Approval Date

2007-06-20

Regulatory Status

RX

2007
20 Jun
RX Application: 21990

Drug Name

EXFORGE

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE;160MG

Approval Date

2007-06-20

21990 / 3

Active Ingredient

AMLODIPINE BESYLATE; VALSARTAN

Application Number

21990

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE;160MG

Approval Date

2007-06-20

Regulatory Status

RX

2007
20 Jun
RX Application: 21990

Drug Name

EXFORGE

Product Number

4

Dosage Form

-

Strength

EQ 5MG BASE;320MG

Approval Date

2007-06-20

21990 / 4

Active Ingredient

AMLODIPINE BESYLATE; VALSARTAN

Application Number

21990

Product Number

4

Dosage Form

-

Strength

EQ 5MG BASE;320MG

Approval Date

2007-06-20

Regulatory Status

RX

2007
20 Jun
RX Application: 21990

Drug Name

EXFORGE

Product Number

5

Dosage Form

-

Strength

EQ 10MG BASE;320MG

Approval Date

2007-06-20

21990 / 5

Active Ingredient

AMLODIPINE BESYLATE; VALSARTAN

Application Number

21990

Product Number

5

Dosage Form

-

Strength

EQ 10MG BASE;320MG

Approval Date

2007-06-20

Regulatory Status

RX

2009
30 Apr
RX Application: 22314

Drug Name

EXFORGE HCT

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;12.5MG;160MG

Approval Date

2009-04-30

22314 / 1

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

22314

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE;12.5MG;160MG

Approval Date

2009-04-30

Regulatory Status

RX

2009
30 Apr
RX Application: 22314

Drug Name

EXFORGE HCT

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;25MG;160MG

Approval Date

2009-04-30

22314 / 2

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

22314

Product Number

2

Dosage Form

-

Strength

EQ 5MG BASE;25MG;160MG

Approval Date

2009-04-30

Regulatory Status

RX

2009
30 Apr
RX Application: 22314

Drug Name

EXFORGE HCT

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE;12.5MG;160MG

Approval Date

2009-04-30

22314 / 3

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

22314

Product Number

3

Dosage Form

-

Strength

EQ 10MG BASE;12.5MG;160MG

Approval Date

2009-04-30

Regulatory Status

RX

2009
30 Apr
RX Application: 22314

Drug Name

EXFORGE HCT

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;25MG;160MG

Approval Date

2009-04-30

22314 / 4

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

22314

Product Number

4

Dosage Form

-

Strength

EQ 10MG BASE;25MG;160MG

Approval Date

2009-04-30

Regulatory Status

RX

2009
30 Apr
RX Application: 22314

Drug Name

EXFORGE HCT

Product Number

5

Dosage Form

-

Strength

EQ 10MG BASE;25MG;320MG

Approval Date

2009-04-30

22314 / 5

Active Ingredient

AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN

Application Number

22314

Product Number

5

Dosage Form

-

Strength

EQ 10MG BASE;25MG;320MG

Approval Date

2009-04-30

Regulatory Status

RX

2005
02 Nov
RX Application: 21882

Drug Name

EXJADE

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2005-11-02

21882 / 1

Active Ingredient

DEFERASIROX

Application Number

21882

Product Number

1

Dosage Form

-

Strength

125MG

Approval Date

2005-11-02

Regulatory Status

RX

2005
02 Nov
RX Application: 21882

Drug Name

EXJADE

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2005-11-02

21882 / 2

Active Ingredient

DEFERASIROX

Application Number

21882

Product Number

2

Dosage Form

-

Strength

250MG

Approval Date

2005-11-02

Regulatory Status

RX

2005
02 Nov
RX Application: 21882

Drug Name

EXJADE

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2005-11-02

21882 / 3

Active Ingredient

DEFERASIROX

Application Number

21882

Product Number

3

Dosage Form

-

Strength

500MG

Approval Date

2005-11-02

Regulatory Status

RX

2023
05 Dec
RX Application: 218276

Drug Name

FABHALTA

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2023-12-05

218276 / 1

Active Ingredient

IPTACOPAN HYDROCHLORIDE

Application Number

218276

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2023-12-05

Regulatory Status

RX

1997
25 Jul
RX Application: 20726

Drug Name

FEMARA

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

1997-07-25

20726 / 1

Active Ingredient

LETROZOLE

Application Number

20726

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

1997-07-25

Regulatory Status

RX

2010
21 Sep
RX Application: 22527

Drug Name

GILENYA

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2010-09-21

22527 / 1

Active Ingredient

FINGOLIMOD HYDROCHLORIDE

Application Number

22527

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2010-09-21

Regulatory Status

RX

2018
11 May
RX Application: 22527

Drug Name

GILENYA

Product Number

2

Dosage Form

-

Strength

EQ 0.25MG BASE

Approval Date

2018-05-11

22527 / 2

Active Ingredient

FINGOLIMOD HYDROCHLORIDE

Application Number

22527

Product Number

2

Dosage Form

-

Strength

EQ 0.25MG BASE

Approval Date

2018-05-11

Regulatory Status

RX

2003
18 Apr
RX Application: 21588

Drug Name

GLEEVEC

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2003-04-18

21588 / 1

Active Ingredient

IMATINIB MESYLATE

Application Number

21588

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2003-04-18

Regulatory Status

RX

2003
18 Apr
RX Application: 21588

Drug Name

GLEEVEC

Product Number

2

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2003-04-18

21588 / 2

Active Ingredient

IMATINIB MESYLATE

Application Number

21588

Product Number

2

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2003-04-18

Regulatory Status

RX

2015
30 Mar
RX Application: 206910

Drug Name

JADENU

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2015-03-30

206910 / 1

Active Ingredient

DEFERASIROX

Application Number

206910

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2015-03-30

Regulatory Status

RX

2015
30 Mar
RX Application: 206910

Drug Name

JADENU

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2015-03-30

206910 / 2

Active Ingredient

DEFERASIROX

Application Number

206910

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2015-03-30

Regulatory Status

RX

2015
30 Mar
RX Application: 206910

Drug Name

JADENU

Product Number

3

Dosage Form

-

Strength

360MG

Approval Date

2015-03-30

206910 / 3

Active Ingredient

DEFERASIROX

Application Number

206910

Product Number

3

Dosage Form

-

Strength

360MG

Approval Date

2015-03-30

Regulatory Status

RX

2017
18 May
RX Application: 207968

Drug Name

JADENU SPRINKLE

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2017-05-18

207968 / 1

Active Ingredient

DEFERASIROX

Application Number

207968

Product Number

1

Dosage Form

-

Strength

90MG

Approval Date

2017-05-18

Regulatory Status

RX

2017
18 May
RX Application: 207968

Drug Name

JADENU SPRINKLE

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2017-05-18

207968 / 2

Active Ingredient

DEFERASIROX

Application Number

207968

Product Number

2

Dosage Form

-

Strength

180MG

Approval Date

2017-05-18

Regulatory Status

RX

2017
18 May
RX Application: 207968

Drug Name

JADENU SPRINKLE

Product Number

3

Dosage Form

-

Strength

360MG

Approval Date

2017-05-18

207968 / 3

Active Ingredient

DEFERASIROX

Application Number

207968

Product Number

3

Dosage Form

-

Strength

360MG

Approval Date

2017-05-18

Regulatory Status

RX

2017
13 Mar
RX Application: 209092

Drug Name

KISQALI

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2017-03-13

209092 / 1

Active Ingredient

RIBOCICLIB SUCCINATE

Application Number

209092

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2017-03-13

Regulatory Status

RX

2017
04 May
RX Application: 209935

Drug Name

KISQALI FEMARA CO-PACK (COPACKAGED)

Product Number

1

Dosage Form

-

Strength

2.5MG;EQ 200MG BASE

Approval Date

2017-05-04

209935 / 1

Active Ingredient

LETROZOLE; RIBOCICLIB SUCCINATE

Application Number

209935

Product Number

1

Dosage Form

-

Strength

2.5MG;EQ 200MG BASE

Approval Date

2017-05-04

Regulatory Status

RX

2021
22 Dec
RX Application: 214012

Drug Name

LEQVIO

Product Number

1

Dosage Form

-

Strength

EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)

Approval Date

2021-12-22

214012 / 1

Active Ingredient

INCLISIRAN SODIUM

Application Number

214012

Product Number

1

Dosage Form

-

Strength

EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)

Approval Date

2021-12-22

Regulatory Status

RX

2022
23 Mar
RX Application: 215841

Drug Name

LOCAMETZ

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

2022-03-23

215841 / 1

Active Ingredient

GALLIUM GA-68 GOZETOTIDE

Application Number

215841

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

2022-03-23

Regulatory Status

RX

2019
26 Mar
RX Application: 209884

Drug Name

MAYZENT

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE

Approval Date

2019-03-26

209884 / 1

Active Ingredient

SIPONIMOD

Application Number

209884

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE

Approval Date

2019-03-26

Regulatory Status

RX

2019
26 Mar
RX Application: 209884

Drug Name

MAYZENT

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2019-03-26

209884 / 2

Active Ingredient

SIPONIMOD

Application Number

209884

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2019-03-26

Regulatory Status

RX

2021
24 Aug
RX Application: 209884

Drug Name

MAYZENT

Product Number

3

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2021-08-24

209884 / 3

Active Ingredient

SIPONIMOD

Application Number

209884

Product Number

3

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2021-08-24

Regulatory Status

RX

2013
29 May
RX Application: 204114

Drug Name

MEKINIST

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG

Approval Date

2013-05-29

204114 / 1

Active Ingredient

TRAMETINIB DIMETHYL SULFOXIDE

Application Number

204114

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG

Approval Date

2013-05-29

Regulatory Status

RX

2013
29 May
RX Application: 204114

Drug Name

MEKINIST

Product Number

3

Dosage Form

-

Strength

EQ 2MG

Approval Date

2013-05-29

204114 / 3

Active Ingredient

TRAMETINIB DIMETHYL SULFOXIDE

Application Number

204114

Product Number

3

Dosage Form

-

Strength

EQ 2MG

Approval Date

2013-05-29

Regulatory Status

RX

2023
16 Mar
RX Application: 217513

Drug Name

MEKINIST

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

2023-03-16

217513 / 1

Active Ingredient

TRAMETINIB DIMETHYL SULFOXIDE

Application Number

217513

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

2023-03-16

Regulatory Status

RX

2004
27 Feb
RX Application: 50791

Drug Name

MYFORTIC

Product Number

1

Dosage Form

-

Strength

EQ 180MG BASE

Approval Date

2004-02-27

50791 / 1

Active Ingredient

MYCOPHENOLATE SODIUM

Application Number

50791

Product Number

1

Dosage Form

-

Strength

EQ 180MG BASE

Approval Date

2004-02-27

Regulatory Status

RX

2004
27 Feb
RX Application: 50791

Drug Name

MYFORTIC

Product Number

2

Dosage Form

-

Strength

EQ 360MG BASE

Approval Date

2004-02-27

50791 / 2

Active Ingredient

MYCOPHENOLATE SODIUM

Application Number

50791

Product Number

2

Dosage Form

-

Strength

EQ 360MG BASE

Approval Date

2004-02-27

Regulatory Status

RX

1995
14 Jul
RX Application: 50715

Drug Name

NEORAL

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1995-07-14

50715 / 1

Active Ingredient

CYCLOSPORINE

Application Number

50715

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1995-07-14

Regulatory Status

RX

1995
14 Jul
RX Application: 50715

Drug Name

NEORAL

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1995-07-14

50715 / 2

Active Ingredient

CYCLOSPORINE

Application Number

50715

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1995-07-14

Regulatory Status

RX

1995
14 Jul
RX Application: 50716

Drug Name

NEORAL

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1995-07-14

50716 / 1

Active Ingredient

CYCLOSPORINE

Application Number

50716

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1995-07-14

Regulatory Status

RX

2016
01 Jun
RX Application: 208547

Drug Name

NETSPOT

Product Number

1

Dosage Form

-

Strength

2.1-5.5mCi/ML

Approval Date

2016-06-01

208547 / 1

Active Ingredient

GALLIUM DOTATATE GA-68

Application Number

208547

Product Number

1

Dosage Form

-

Strength

2.1-5.5mCi/ML

Approval Date

2016-06-01

Regulatory Status

RX

2019
24 May
RX Application: 212526

Drug Name

PIQRAY

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2019-05-24

212526 / 1

Active Ingredient

ALPELISIB

Application Number

212526

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2019-05-24

Regulatory Status

RX

2019
24 May
RX Application: 212526

Drug Name

PIQRAY

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2019-05-24

212526 / 2

Active Ingredient

ALPELISIB

Application Number

212526

Product Number

2

Dosage Form

-

Strength

150MG

Approval Date

2019-05-24

Regulatory Status

RX

2019
24 May
RX Application: 212526

Drug Name

PIQRAY

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2019-05-24

212526 / 3

Active Ingredient

ALPELISIB

Application Number

212526

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2019-05-24

Regulatory Status

RX

2022
23 Mar
RX Application: 215833

Drug Name

PLUVICTO

Product Number

1

Dosage Form

-

Strength

27mCi/ML

Approval Date

2022-03-23

215833 / 1

Active Ingredient

LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN

Application Number

215833

Product Number

1

Dosage Form

-

Strength

27mCi/ML

Approval Date

2022-03-23

Regulatory Status

RX

2008
20 Nov
RX Application: 22291

Drug Name

PROMACTA

Product Number

1

Dosage Form

-

Strength

EQ 25MG ACID

Approval Date

2008-11-20

22291 / 1

Active Ingredient

ELTROMBOPAG OLAMINE

Application Number

22291

Product Number

1

Dosage Form

-

Strength

EQ 25MG ACID

Approval Date

2008-11-20

Regulatory Status

RX

2008
20 Nov
RX Application: 22291

Drug Name

PROMACTA

Product Number

2

Dosage Form

-

Strength

EQ 50MG ACID

Approval Date

2008-11-20

22291 / 2

Active Ingredient

ELTROMBOPAG OLAMINE

Application Number

22291

Product Number

2

Dosage Form

-

Strength

EQ 50MG ACID

Approval Date

2008-11-20

Regulatory Status

RX

2009
08 Sep
RX Application: 22291

Drug Name

PROMACTA

Product Number

3

Dosage Form

-

Strength

EQ 75MG ACID

Approval Date

2009-09-08

22291 / 3

Active Ingredient

ELTROMBOPAG OLAMINE

Application Number

22291

Product Number

3

Dosage Form

-

Strength

EQ 75MG ACID

Approval Date

2009-09-08

Regulatory Status

RX

2011
20 Oct
RX Application: 22291

Drug Name

PROMACTA

Product Number

4

Dosage Form

-

Strength

EQ 12.5MG ACID

Approval Date

2011-10-20

22291 / 4

Active Ingredient

ELTROMBOPAG OLAMINE

Application Number

22291

Product Number

4

Dosage Form

-

Strength

EQ 12.5MG ACID

Approval Date

2011-10-20

Regulatory Status

RX

2015
24 Aug
RX Application: 207027

Drug Name

PROMACTA KIT

Product Number

1

Dosage Form

-

Strength

EQ 25MG ACID/PACKET

Approval Date

2015-08-24

207027 / 1

Active Ingredient

ELTROMBOPAG OLAMINE

Application Number

207027

Product Number

1

Dosage Form

-

Strength

EQ 25MG ACID/PACKET

Approval Date

2015-08-24

Regulatory Status

RX

2018
27 Sep
RX Application: 207027

Drug Name

PROMACTA KIT

Product Number

2

Dosage Form

-

Strength

EQ 12.5MG ACID/PACKET

Approval Date

2018-09-27

207027 / 2

Active Ingredient

ELTROMBOPAG OLAMINE

Application Number

207027

Product Number

2

Dosage Form

-

Strength

EQ 12.5MG ACID/PACKET

Approval Date

2018-09-27

Regulatory Status

RX

2025
30 Sep
RX Application: 218436

Drug Name

RHAPSIDO

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2025-09-30

218436 / 1

Active Ingredient

REMIBRUTINIB

Application Number

218436

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2025-09-30

Regulatory Status

RX

2017
28 Apr
RX Application: 207997

Drug Name

RYDAPT

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2017-04-28

207997 / 1

Active Ingredient

MIDOSTAURIN

Application Number

207997

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2017-04-28

Regulatory Status

RX

1983
14 Nov
RX Application: 50573

Drug Name

SANDIMMUNE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1983-11-14

50573 / 1

Active Ingredient

CYCLOSPORINE

Application Number

50573

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

1983-11-14

Regulatory Status

RX

1983
14 Nov
RX Application: 50574

Drug Name

SANDIMMUNE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1983-11-14

50574 / 1

Active Ingredient

CYCLOSPORINE

Application Number

50574

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1983-11-14

Regulatory Status

RX

1990
02 Mar
RX Application: 50625

Drug Name

SANDIMMUNE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1990-03-02

50625 / 1

Active Ingredient

CYCLOSPORINE

Application Number

50625

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1990-03-02

Regulatory Status

RX

1990
02 Mar
RX Application: 50625

Drug Name

SANDIMMUNE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1990-03-02

50625 / 2

Active Ingredient

CYCLOSPORINE

Application Number

50625

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

1990-03-02

Regulatory Status

RX

1992
23 Nov
RX Application: 50625

Drug Name

SANDIMMUNE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1992-11-23

50625 / 3

Active Ingredient

CYCLOSPORINE

Application Number

50625

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

1992-11-23

Regulatory Status

RX

1988
21 Oct
RX Application: 19667

Drug Name

SANDOSTATIN

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

1988-10-21

19667 / 1

Active Ingredient

OCTREOTIDE ACETATE

Application Number

19667

Product Number

1

Dosage Form

-

Strength

EQ 0.05MG BASE/ML

Approval Date

1988-10-21

Regulatory Status

RX

1988
21 Oct
RX Application: 19667

Drug Name

SANDOSTATIN

Product Number

2

Dosage Form

-

Strength

EQ 0.1MG BASE/ML

Approval Date

1988-10-21

19667 / 2

Active Ingredient

OCTREOTIDE ACETATE

Application Number

19667

Product Number

2

Dosage Form

-

Strength

EQ 0.1MG BASE/ML

Approval Date

1988-10-21

Regulatory Status

RX

1988
21 Oct
RX Application: 19667

Drug Name

SANDOSTATIN

Product Number

3

Dosage Form

-

Strength

EQ 0.5MG BASE/ML

Approval Date

1988-10-21

19667 / 3

Active Ingredient

OCTREOTIDE ACETATE

Application Number

19667

Product Number

3

Dosage Form

-

Strength

EQ 0.5MG BASE/ML

Approval Date

1988-10-21

Regulatory Status

RX

1998
25 Nov
RX Application: 21008

Drug Name

SANDOSTATIN LAR

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/VIAL

Approval Date

1998-11-25

21008 / 1

Active Ingredient

OCTREOTIDE ACETATE

Application Number

21008

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/VIAL

Approval Date

1998-11-25

Regulatory Status

RX

1998
25 Nov
RX Application: 21008

Drug Name

SANDOSTATIN LAR

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE/VIAL

Approval Date

1998-11-25

21008 / 2

Active Ingredient

OCTREOTIDE ACETATE

Application Number

21008

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE/VIAL

Approval Date

1998-11-25

Regulatory Status

RX

1998
25 Nov
RX Application: 21008

Drug Name

SANDOSTATIN LAR

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE/VIAL

Approval Date

1998-11-25

21008 / 3

Active Ingredient

OCTREOTIDE ACETATE

Application Number

21008

Product Number

3

Dosage Form

-

Strength

EQ 30MG BASE/VIAL

Approval Date

1998-11-25

Regulatory Status

RX

2021
29 Oct
RX Application: 215358

Drug Name

SCEMBLIX

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2021-10-29

215358 / 1

Active Ingredient

ASCIMINIB HYDROCHLORIDE

Application Number

215358

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2021-10-29

Regulatory Status

RX

2021
29 Oct
RX Application: 215358

Drug Name

SCEMBLIX

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2021-10-29

215358 / 2

Active Ingredient

ASCIMINIB HYDROCHLORIDE

Application Number

215358

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2021-10-29

Regulatory Status

RX

2024
18 Apr
RX Application: 215358

Drug Name

SCEMBLIX

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2024-04-18

215358 / 3

Active Ingredient

ASCIMINIB HYDROCHLORIDE

Application Number

215358

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2024-04-18

Regulatory Status

RX

2020
06 May
RX Application: 213591

Drug Name

TABRECTA

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2020-05-06

213591 / 1

Active Ingredient

CAPMATINIB HYDROCHLORIDE

Application Number

213591

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2020-05-06

Regulatory Status

RX

2020
06 May
RX Application: 213591

Drug Name

TABRECTA

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2020-05-06

213591 / 2

Active Ingredient

CAPMATINIB HYDROCHLORIDE

Application Number

213591

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2020-05-06

Regulatory Status

RX

2013
29 May
RX Application: 202806

Drug Name

TAFINLAR

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2013-05-29

202806 / 1

Active Ingredient

DABRAFENIB MESYLATE

Application Number

202806

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2013-05-29

Regulatory Status

RX

2013
29 May
RX Application: 202806

Drug Name

TAFINLAR

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2013-05-29

202806 / 2

Active Ingredient

DABRAFENIB MESYLATE

Application Number

202806

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2013-05-29

Regulatory Status

RX

2023
16 Mar
RX Application: 217514

Drug Name

TAFINLAR

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2023-03-16

217514 / 1

Active Ingredient

DABRAFENIB MESYLATE

Application Number

217514

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2023-03-16

Regulatory Status

RX

2007
29 Oct
RX Application: 22068

Drug Name

TASIGNA

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2007-10-29

22068 / 1

Active Ingredient

NILOTINIB HYDROCHLORIDE

Application Number

22068

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2007-10-29

Regulatory Status

RX

2010
17 Jun
RX Application: 22068

Drug Name

TASIGNA

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2010-06-17

22068 / 2

Active Ingredient

NILOTINIB HYDROCHLORIDE

Application Number

22068

Product Number

2

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2010-06-17

Regulatory Status

RX

2018
22 Mar
RX Application: 22068

Drug Name

TASIGNA

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2018-03-22

22068 / 3

Active Ingredient

NILOTINIB HYDROCHLORIDE

Application Number

22068

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2018-03-22

Regulatory Status

RX

1982
01 Jan
RX Application: 16608

Drug Name

TEGRETOL

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

16608 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

16608

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

RX

1987
18 Dec
RX Application: 18927

Drug Name

TEGRETOL

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

1987-12-18

18927 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

18927

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

1987-12-18

Regulatory Status

RX

1996
25 Mar
RX Application: 20234

Drug Name

TEGRETOL-XR

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1996-03-25

20234 / 1

Active Ingredient

CARBAMAZEPINE

Application Number

20234

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1996-03-25

Regulatory Status

RX

1996
25 Mar
RX Application: 20234

Drug Name

TEGRETOL-XR

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1996-03-25

20234 / 2

Active Ingredient

CARBAMAZEPINE

Application Number

20234

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1996-03-25

Regulatory Status

RX

1996
25 Mar
RX Application: 20234

Drug Name

TEGRETOL-XR

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

1996-03-25

20234 / 3

Active Ingredient

CARBAMAZEPINE

Application Number

20234

Product Number

3

Dosage Form

-

Strength

400MG

Approval Date

1996-03-25

Regulatory Status

RX

1988
28 Sep
RX Application: 50616

Drug Name

TOBRADEX

Product Number

1

Dosage Form

-

Strength

0.1%;0.3%

Approval Date

1988-09-28

50616 / 1

Active Ingredient

DEXAMETHASONE; TOBRAMYCIN

Application Number

50616

Product Number

1

Dosage Form

-

Strength

0.1%;0.3%

Approval Date

1988-09-28

Regulatory Status

RX

1982
01 Jan
RX Application: 50555

Drug Name

TOBREX

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

1982-01-01

50555 / 1

Active Ingredient

TOBRAMYCIN

Application Number

50555

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

1982-01-01

Regulatory Status

RX

2000
14 Jan
RX Application: 21014

Drug Name

TRILEPTAL

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2000-01-14

21014 / 1

Active Ingredient

OXCARBAZEPINE

Application Number

21014

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2000-01-14

Regulatory Status

RX

2000
14 Jan
RX Application: 21014

Drug Name

TRILEPTAL

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2000-01-14

21014 / 2

Active Ingredient

OXCARBAZEPINE

Application Number

21014

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2000-01-14

Regulatory Status

RX

2000
14 Jan
RX Application: 21014

Drug Name

TRILEPTAL

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2000-01-14

21014 / 3

Active Ingredient

OXCARBAZEPINE

Application Number

21014

Product Number

3

Dosage Form

-

Strength

600MG

Approval Date

2000-01-14

Regulatory Status

RX

2001
25 May
RX Application: 21285

Drug Name

TRILEPTAL

Product Number

1

Dosage Form

-

Strength

300MG/5ML

Approval Date

2001-05-25

21285 / 1

Active Ingredient

OXCARBAZEPINE

Application Number

21285

Product Number

1

Dosage Form

-

Strength

300MG/5ML

Approval Date

2001-05-25

Regulatory Status

RX

2007
13 Mar
RX Application: 22059

Drug Name

TYKERB

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2007-03-13

22059 / 1

Active Ingredient

LAPATINIB DITOSYLATE

Application Number

22059

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE

Approval Date

2007-03-13

Regulatory Status

RX

2025
02 Apr
RX Application: 219208

Drug Name

VANRAFIA

Product Number

1

Dosage Form

-

Strength

EQ 0.75MG BASE

Approval Date

2025-04-02

219208 / 1

Active Ingredient

ATRASENTAN HYDROCHLORIDE

Application Number

219208

Product Number

1

Dosage Form

-

Strength

EQ 0.75MG BASE

Approval Date

2025-04-02

Regulatory Status

RX

2022
05 Apr
RX Application: 215039

Drug Name

VIJOICE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2022-04-05

215039 / 1

Active Ingredient

ALPELISIB

Application Number

215039

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2022-04-05

Regulatory Status

RX

2022
05 Apr
RX Application: 215039

Drug Name

VIJOICE

Product Number

2

Dosage Form

-

Strength

125MG

Approval Date

2022-04-05

215039 / 2

Active Ingredient

ALPELISIB

Application Number

215039

Product Number

2

Dosage Form

-

Strength

125MG

Approval Date

2022-04-05

Regulatory Status

RX

2022
05 Apr
RX Application: 215039

Drug Name

VIJOICE

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2022-04-05

215039 / 3

Active Ingredient

ALPELISIB

Application Number

215039

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2022-04-05

Regulatory Status

RX

2024
24 Apr
RX Application: 218466

Drug Name

VIJOICE

Product Number

1

Dosage Form

-

Strength

50MG/PACKET

Approval Date

2024-04-24

218466 / 1

Active Ingredient

ALPELISIB

Application Number

218466

Product Number

1

Dosage Form

-

Strength

50MG/PACKET

Approval Date

2024-04-24

Regulatory Status

RX

2009
19 Oct
RX Application: 22465

Drug Name

VOTRIENT

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2009-10-19

22465 / 1

Active Ingredient

PAZOPANIB HYDROCHLORIDE

Application Number

22465

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2009-10-19

Regulatory Status

RX

2010
20 Apr
RX Application: 21560

Drug Name

ZORTRESS

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2010-04-20

21560 / 1

Active Ingredient

EVEROLIMUS

Application Number

21560

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2010-04-20

Regulatory Status

RX

2010
20 Apr
RX Application: 21560

Drug Name

ZORTRESS

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2010-04-20

21560 / 2

Active Ingredient

EVEROLIMUS

Application Number

21560

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2010-04-20

Regulatory Status

RX

2010
20 Apr
RX Application: 21560

Drug Name

ZORTRESS

Product Number

3

Dosage Form

-

Strength

0.75MG

Approval Date

2010-04-20

21560 / 3

Active Ingredient

EVEROLIMUS

Application Number

21560

Product Number

3

Dosage Form

-

Strength

0.75MG

Approval Date

2010-04-20

Regulatory Status

RX

2018
10 Aug
RX Application: 21560

Drug Name

ZORTRESS

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

2018-08-10

21560 / 4

Active Ingredient

EVEROLIMUS

Application Number

21560

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

2018-08-10

Regulatory Status

RX

2019
18 Mar
RX Application: 211225

Drug Name

ZYKADIA

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2019-03-18

211225 / 1

Active Ingredient

CERITINIB

Application Number

211225

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2019-03-18

Regulatory Status

RX

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Drug Status Breakdown
121 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

AFINITOR

Application Number

22334

Product Number

1

Active Ingredient

EVEROLIMUS

Dosage Form

-

Strength

5MG

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

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Searchable pharmaceutical data

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Organized FDA drug records

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