Johnson & Johnson Innovative Medicine RX
FDA Approved Drugs

Johnson & Johnson Innovative Medicine 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 65
  • Latest Approval Date Feb 27, 2026
  • Data Source FDA
  • First Approval Date Sep 11, 1992
All
154
View
Unclassified
6
View
Discontinued
83
View
RX
65
View
Company Overview

Company

Johnson & Johnson Innovative Medicine RX

Country

U.S.A

Website

Visit Website

Email

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Company Snapshot

Johnson & Johnson Innovative Medicine RX

1125 Trenton-Harbourton Road, P.O. Box 200, Titusville, NJ 08560

U.S.A

www.janssen.com/us/ View on Map
FDA Approved Drug Records ( 65 records )
2000
01 Aug
RX Application: 21121

Drug Name

CONCERTA

Product Number

1

Dosage Form

-

Strength

18MG

Approval Date

2000-08-01

21121 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

21121

Product Number

1

Dosage Form

-

Strength

18MG

Approval Date

2000-08-01

Regulatory Status

RX

2000
01 Aug
RX Application: 21121

Drug Name

CONCERTA

Product Number

2

Dosage Form

-

Strength

36MG

Approval Date

2000-08-01

21121 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

21121

Product Number

2

Dosage Form

-

Strength

36MG

Approval Date

2000-08-01

Regulatory Status

RX

2000
08 Dec
RX Application: 21121

Drug Name

CONCERTA

Product Number

3

Dosage Form

-

Strength

54MG

Approval Date

2000-12-08

21121 / 3

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

21121

Product Number

3

Dosage Form

-

Strength

54MG

Approval Date

2000-12-08

Regulatory Status

RX

2002
01 Apr
RX Application: 21121

Drug Name

CONCERTA

Product Number

4

Dosage Form

-

Strength

27MG

Approval Date

2002-04-01

21121 / 4

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

21121

Product Number

4

Dosage Form

-

Strength

27MG

Approval Date

2002-04-01

Regulatory Status

RX

2011
20 May
RX Application: 202022

Drug Name

EDURANT

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2011-05-20

202022 / 1

Active Ingredient

RILPIVIRINE HYDROCHLORIDE

Application Number

202022

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2011-05-20

Regulatory Status

RX

2024
15 Mar
RX Application: 219016

Drug Name

EDURANT PED

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2024-03-15

219016 / 1

Active Ingredient

RILPIVIRINE HYDROCHLORIDE

Application Number

219016

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2024-03-15

Regulatory Status

RX

1996
26 Sep
RX Application: 20193

Drug Name

ELMIRON

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1996-09-26

20193 / 1

Active Ingredient

PENTOSAN POLYSULFATE SODIUM

Application Number

20193

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1996-09-26

Regulatory Status

RX

2006
19 Dec
RX Application: 21999

Drug Name

INVEGA

Product Number

1

Dosage Form

-

Strength

3MG

Approval Date

2006-12-19

21999 / 1

Active Ingredient

PALIPERIDONE

Application Number

21999

Product Number

1

Dosage Form

-

Strength

3MG

Approval Date

2006-12-19

Regulatory Status

RX

2006
19 Dec
RX Application: 21999

Drug Name

INVEGA

Product Number

2

Dosage Form

-

Strength

6MG

Approval Date

2006-12-19

21999 / 2

Active Ingredient

PALIPERIDONE

Application Number

21999

Product Number

2

Dosage Form

-

Strength

6MG

Approval Date

2006-12-19

Regulatory Status

RX

2006
19 Dec
RX Application: 21999

Drug Name

INVEGA

Product Number

3

Dosage Form

-

Strength

9MG

Approval Date

2006-12-19

21999 / 3

Active Ingredient

PALIPERIDONE

Application Number

21999

Product Number

3

Dosage Form

-

Strength

9MG

Approval Date

2006-12-19

Regulatory Status

RX

2021
30 Aug
RX Application: 207946

Drug Name

INVEGA HAFYERA

Product Number

5

Dosage Form

-

Strength

1.092GM/3.5ML (312MG/ML)

Approval Date

2021-08-30

207946 / 5

Active Ingredient

PALIPERIDONE PALMITATE

Application Number

207946

Product Number

5

Dosage Form

-

Strength

1.092GM/3.5ML (312MG/ML)

Approval Date

2021-08-30

Regulatory Status

RX

2021
30 Aug
RX Application: 207946

Drug Name

INVEGA HAFYERA

Product Number

6

Dosage Form

-

Strength

1.560GM/5ML (312MG/ML)

Approval Date

2021-08-30

207946 / 6

Active Ingredient

PALIPERIDONE PALMITATE

Application Number

207946

Product Number

6

Dosage Form

-

Strength

1.560GM/5ML (312MG/ML)

Approval Date

2021-08-30

Regulatory Status

RX

2009
31 Jul
RX Application: 22264

Drug Name

INVEGA SUSTENNA

Product Number

1

Dosage Form

-

Strength

39MG/0.25ML (39MG/0.25ML)

Approval Date

2009-07-31

22264 / 1

Active Ingredient

PALIPERIDONE PALMITATE

Application Number

22264

Product Number

1

Dosage Form

-

Strength

39MG/0.25ML (39MG/0.25ML)

Approval Date

2009-07-31

Regulatory Status

RX

2009
31 Jul
RX Application: 22264

Drug Name

INVEGA SUSTENNA

Product Number

2

Dosage Form

-

Strength

78MG/0.5ML (78MG/0.5ML)

Approval Date

2009-07-31

22264 / 2

Active Ingredient

PALIPERIDONE PALMITATE

Application Number

22264

Product Number

2

Dosage Form

-

Strength

78MG/0.5ML (78MG/0.5ML)

Approval Date

2009-07-31

Regulatory Status

RX

2009
31 Jul
RX Application: 22264

Drug Name

INVEGA SUSTENNA

Product Number

3

Dosage Form

-

Strength

117MG/0.75ML (117MG/0.75ML)

Approval Date

2009-07-31

22264 / 3

Active Ingredient

PALIPERIDONE PALMITATE

Application Number

22264

Product Number

3

Dosage Form

-

Strength

117MG/0.75ML (117MG/0.75ML)

Approval Date

2009-07-31

Regulatory Status

RX

2009
31 Jul
RX Application: 22264

Drug Name

INVEGA SUSTENNA

Product Number

4

Dosage Form

-

Strength

156MG/ML (156MG/ML)

Approval Date

2009-07-31

22264 / 4

Active Ingredient

PALIPERIDONE PALMITATE

Application Number

22264

Product Number

4

Dosage Form

-

Strength

156MG/ML (156MG/ML)

Approval Date

2009-07-31

Regulatory Status

RX

2009
31 Jul
RX Application: 22264

Drug Name

INVEGA SUSTENNA

Product Number

5

Dosage Form

-

Strength

234MG/1.5ML (156MG/ML)

Approval Date

2009-07-31

22264 / 5

Active Ingredient

PALIPERIDONE PALMITATE

Application Number

22264

Product Number

5

Dosage Form

-

Strength

234MG/1.5ML (156MG/ML)

Approval Date

2009-07-31

Regulatory Status

RX

2015
18 May
RX Application: 207946

Drug Name

INVEGA TRINZA

Product Number

1

Dosage Form

-

Strength

273MG/0.875ML (273MG/0.875ML)

Approval Date

2015-05-18

207946 / 1

Active Ingredient

PALIPERIDONE PALMITATE

Application Number

207946

Product Number

1

Dosage Form

-

Strength

273MG/0.875ML (273MG/0.875ML)

Approval Date

2015-05-18

Regulatory Status

RX

2015
18 May
RX Application: 207946

Drug Name

INVEGA TRINZA

Product Number

2

Dosage Form

-

Strength

410MG/1.315ML (311.79MG/ML)

Approval Date

2015-05-18

207946 / 2

Active Ingredient

PALIPERIDONE PALMITATE

Application Number

207946

Product Number

2

Dosage Form

-

Strength

410MG/1.315ML (311.79MG/ML)

Approval Date

2015-05-18

Regulatory Status

RX

2015
18 May
RX Application: 207946

Drug Name

INVEGA TRINZA

Product Number

3

Dosage Form

-

Strength

546MG/1.75ML (312MG/ML)

Approval Date

2015-05-18

207946 / 3

Active Ingredient

PALIPERIDONE PALMITATE

Application Number

207946

Product Number

3

Dosage Form

-

Strength

546MG/1.75ML (312MG/ML)

Approval Date

2015-05-18

Regulatory Status

RX

2015
18 May
RX Application: 207946

Drug Name

INVEGA TRINZA

Product Number

4

Dosage Form

-

Strength

819MG/2.625ML (312MG/ML)

Approval Date

2015-05-18

207946 / 4

Active Ingredient

PALIPERIDONE PALMITATE

Application Number

207946

Product Number

4

Dosage Form

-

Strength

819MG/2.625ML (312MG/ML)

Approval Date

2015-05-18

Regulatory Status

RX

2014
08 Aug
RX Application: 204353

Drug Name

INVOKAMET

Product Number

1

Dosage Form

-

Strength

50MG;500MG

Approval Date

2014-08-08

204353 / 1

Active Ingredient

CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

204353

Product Number

1

Dosage Form

-

Strength

50MG;500MG

Approval Date

2014-08-08

Regulatory Status

RX

2014
08 Aug
RX Application: 204353

Drug Name

INVOKAMET

Product Number

2

Dosage Form

-

Strength

50MG;1GM

Approval Date

2014-08-08

204353 / 2

Active Ingredient

CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

204353

Product Number

2

Dosage Form

-

Strength

50MG;1GM

Approval Date

2014-08-08

Regulatory Status

RX

2014
08 Aug
RX Application: 204353

Drug Name

INVOKAMET

Product Number

3

Dosage Form

-

Strength

150MG;500MG

Approval Date

2014-08-08

204353 / 3

Active Ingredient

CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

204353

Product Number

3

Dosage Form

-

Strength

150MG;500MG

Approval Date

2014-08-08

Regulatory Status

RX

2014
08 Aug
RX Application: 204353

Drug Name

INVOKAMET

Product Number

4

Dosage Form

-

Strength

150MG;1GM

Approval Date

2014-08-08

204353 / 4

Active Ingredient

CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

204353

Product Number

4

Dosage Form

-

Strength

150MG;1GM

Approval Date

2014-08-08

Regulatory Status

RX

2016
20 Sep
RX Application: 205879

Drug Name

INVOKAMET XR

Product Number

1

Dosage Form

-

Strength

50MG;500MG

Approval Date

2016-09-20

205879 / 1

Active Ingredient

CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

205879

Product Number

1

Dosage Form

-

Strength

50MG;500MG

Approval Date

2016-09-20

Regulatory Status

RX

2016
20 Sep
RX Application: 205879

Drug Name

INVOKAMET XR

Product Number

2

Dosage Form

-

Strength

50MG;1GM

Approval Date

2016-09-20

205879 / 2

Active Ingredient

CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

205879

Product Number

2

Dosage Form

-

Strength

50MG;1GM

Approval Date

2016-09-20

Regulatory Status

RX

2016
20 Sep
RX Application: 205879

Drug Name

INVOKAMET XR

Product Number

3

Dosage Form

-

Strength

150MG;500MG

Approval Date

2016-09-20

205879 / 3

Active Ingredient

CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

205879

Product Number

3

Dosage Form

-

Strength

150MG;500MG

Approval Date

2016-09-20

Regulatory Status

RX

2016
20 Sep
RX Application: 205879

Drug Name

INVOKAMET XR

Product Number

4

Dosage Form

-

Strength

150MG;1GM

Approval Date

2016-09-20

205879 / 4

Active Ingredient

CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE

Application Number

205879

Product Number

4

Dosage Form

-

Strength

150MG;1GM

Approval Date

2016-09-20

Regulatory Status

RX

2013
29 Mar
RX Application: 204042

Drug Name

INVOKANA

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2013-03-29

204042 / 1

Active Ingredient

CANAGLIFLOZIN

Application Number

204042

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2013-03-29

Regulatory Status

RX

2013
29 Mar
RX Application: 204042

Drug Name

INVOKANA

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2013-03-29

204042 / 2

Active Ingredient

CANAGLIFLOZIN

Application Number

204042

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2013-03-29

Regulatory Status

RX

2015
29 Jan
RX Application: 205395

Drug Name

PREZCOBIX

Product Number

1

Dosage Form

-

Strength

150MG;EQ 800MG BASE

Approval Date

2015-01-29

205395 / 1

Active Ingredient

COBICISTAT; DARUNAVIR ETHANOLATE

Application Number

205395

Product Number

1

Dosage Form

-

Strength

150MG;EQ 800MG BASE

Approval Date

2015-01-29

Regulatory Status

RX

2025
21 Mar
RX Application: 205395

Drug Name

PREZCOBIX

Product Number

2

Dosage Form

-

Strength

150MG;EQ 675MG BASE

Approval Date

2025-03-21

205395 / 2

Active Ingredient

COBICISTAT; DARUNAVIR ETHANOLATE

Application Number

205395

Product Number

2

Dosage Form

-

Strength

150MG;EQ 675MG BASE

Approval Date

2025-03-21

Regulatory Status

RX

2026
27 Feb
RX Application: 220092

Drug Name

PREZCOBIX PED

Product Number

1

Dosage Form

-

Strength

90MG;EQ 600MG BASE

Approval Date

2026-02-27

220092 / 1

Active Ingredient

COBICISTAT; DARUNAVIR ETHANOLATE

Application Number

220092

Product Number

1

Dosage Form

-

Strength

90MG;EQ 600MG BASE

Approval Date

2026-02-27

Regulatory Status

RX

2008
25 Feb
RX Application: 21976

Drug Name

PREZISTA

Product Number

2

Dosage Form

-

Strength

600MG

Approval Date

2008-02-25

21976 / 2

Active Ingredient

DARUNAVIR

Application Number

21976

Product Number

2

Dosage Form

-

Strength

600MG

Approval Date

2008-02-25

Regulatory Status

RX

2008
18 Dec
RX Application: 21976

Drug Name

PREZISTA

Product Number

4

Dosage Form

-

Strength

75MG

Approval Date

2008-12-18

21976 / 4

Active Ingredient

DARUNAVIR

Application Number

21976

Product Number

4

Dosage Form

-

Strength

75MG

Approval Date

2008-12-18

Regulatory Status

RX

2008
18 Dec
RX Application: 21976

Drug Name

PREZISTA

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2008-12-18

21976 / 5

Active Ingredient

DARUNAVIR

Application Number

21976

Product Number

5

Dosage Form

-

Strength

150MG

Approval Date

2008-12-18

Regulatory Status

RX

2012
09 Nov
RX Application: 21976

Drug Name

PREZISTA

Product Number

6

Dosage Form

-

Strength

800MG

Approval Date

2012-11-09

21976 / 6

Active Ingredient

DARUNAVIR

Application Number

21976

Product Number

6

Dosage Form

-

Strength

800MG

Approval Date

2012-11-09

Regulatory Status

RX

2011
16 Dec
RX Application: 202895

Drug Name

PREZISTA

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2011-12-16

202895 / 1

Active Ingredient

DARUNAVIR

Application Number

202895

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2011-12-16

Regulatory Status

RX

1993
29 Dec
RX Application: 20272

Drug Name

RISPERDAL

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1993-12-29

20272 / 1

Active Ingredient

RISPERIDONE

Application Number

20272

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1993-12-29

Regulatory Status

RX

1993
29 Dec
RX Application: 20272

Drug Name

RISPERDAL

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

1993-12-29

20272 / 2

Active Ingredient

RISPERIDONE

Application Number

20272

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

1993-12-29

Regulatory Status

RX

1993
29 Dec
RX Application: 20272

Drug Name

RISPERDAL

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

1993-12-29

20272 / 3

Active Ingredient

RISPERIDONE

Application Number

20272

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

1993-12-29

Regulatory Status

RX

1993
29 Dec
RX Application: 20272

Drug Name

RISPERDAL

Product Number

4

Dosage Form

-

Strength

4MG

Approval Date

1993-12-29

20272 / 4

Active Ingredient

RISPERIDONE

Application Number

20272

Product Number

4

Dosage Form

-

Strength

4MG

Approval Date

1993-12-29

Regulatory Status

RX

1999
27 Jan
RX Application: 20272

Drug Name

RISPERDAL

Product Number

7

Dosage Form

-

Strength

0.5MG

Approval Date

1999-01-27

20272 / 7

Active Ingredient

RISPERIDONE

Application Number

20272

Product Number

7

Dosage Form

-

Strength

0.5MG

Approval Date

1999-01-27

Regulatory Status

RX

1999
10 May
RX Application: 20272

Drug Name

RISPERDAL

Product Number

8

Dosage Form

-

Strength

0.25MG

Approval Date

1999-05-10

20272 / 8

Active Ingredient

RISPERIDONE

Application Number

20272

Product Number

8

Dosage Form

-

Strength

0.25MG

Approval Date

1999-05-10

Regulatory Status

RX

1996
10 Jun
RX Application: 20588

Drug Name

RISPERDAL

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1996-06-10

20588 / 1

Active Ingredient

RISPERIDONE

Application Number

20588

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1996-06-10

Regulatory Status

RX

2003
29 Oct
RX Application: 21346

Drug Name

RISPERDAL CONSTA

Product Number

1

Dosage Form

-

Strength

25MG/VIAL

Approval Date

2003-10-29

21346 / 1

Active Ingredient

RISPERIDONE

Application Number

21346

Product Number

1

Dosage Form

-

Strength

25MG/VIAL

Approval Date

2003-10-29

Regulatory Status

RX

2003
29 Oct
RX Application: 21346

Drug Name

RISPERDAL CONSTA

Product Number

2

Dosage Form

-

Strength

37.5MG/VIAL

Approval Date

2003-10-29

21346 / 2

Active Ingredient

RISPERIDONE

Application Number

21346

Product Number

2

Dosage Form

-

Strength

37.5MG/VIAL

Approval Date

2003-10-29

Regulatory Status

RX

2003
29 Oct
RX Application: 21346

Drug Name

RISPERDAL CONSTA

Product Number

3

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2003-10-29

21346 / 3

Active Ingredient

RISPERIDONE

Application Number

21346

Product Number

3

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2003-10-29

Regulatory Status

RX

2007
12 Apr
RX Application: 21346

Drug Name

RISPERDAL CONSTA

Product Number

4

Dosage Form

-

Strength

12.5MG/VIAL

Approval Date

2007-04-12

21346 / 4

Active Ingredient

RISPERIDONE

Application Number

21346

Product Number

4

Dosage Form

-

Strength

12.5MG/VIAL

Approval Date

2007-04-12

Regulatory Status

RX

1992
11 Sep
RX Application: 20083

Drug Name

SPORANOX

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1992-09-11

20083 / 1

Active Ingredient

ITRACONAZOLE

Application Number

20083

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1992-09-11

Regulatory Status

RX

2019
05 Mar
RX Application: 211243

Drug Name

SPRAVATO

Product Number

1

Dosage Form

-

Strength

EQ 28MG BASE

Approval Date

2019-03-05

211243 / 1

Active Ingredient

ESKETAMINE HYDROCHLORIDE

Application Number

211243

Product Number

1

Dosage Form

-

Strength

EQ 28MG BASE

Approval Date

2019-03-05

Regulatory Status

RX

2018
17 Jul
RX Application: 210455

Drug Name

SYMTUZA

Product Number

1

Dosage Form

-

Strength

150MG;800MG;200MG;EQ 10MG BASE

Approval Date

2018-07-17

210455 / 1

Active Ingredient

COBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

Application Number

210455

Product Number

1

Dosage Form

-

Strength

150MG;800MG;200MG;EQ 10MG BASE

Approval Date

2018-07-17

Regulatory Status

RX

1996
24 Dec
RX Application: 20505

Drug Name

TOPAMAX

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1996-12-24

20505 / 1

Active Ingredient

TOPIRAMATE

Application Number

20505

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1996-12-24

Regulatory Status

RX

1996
24 Dec
RX Application: 20505

Drug Name

TOPAMAX

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1996-12-24

20505 / 2

Active Ingredient

TOPIRAMATE

Application Number

20505

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1996-12-24

Regulatory Status

RX

1996
24 Dec
RX Application: 20505

Drug Name

TOPAMAX

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

1996-12-24

20505 / 4

Active Ingredient

TOPIRAMATE

Application Number

20505

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

1996-12-24

Regulatory Status

RX

1996
24 Dec
RX Application: 20505

Drug Name

TOPAMAX

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

1996-12-24

20505 / 5

Active Ingredient

TOPIRAMATE

Application Number

20505

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

1996-12-24

Regulatory Status

RX

1998
26 Oct
RX Application: 20844

Drug Name

TOPAMAX

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1998-10-26

20844 / 1

Active Ingredient

TOPIRAMATE

Application Number

20844

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1998-10-26

Regulatory Status

RX

1998
26 Oct
RX Application: 20844

Drug Name

TOPAMAX

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1998-10-26

20844 / 2

Active Ingredient

TOPIRAMATE

Application Number

20844

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

1998-10-26

Regulatory Status

RX

2011
01 Jul
RX Application: 22406

Drug Name

XARELTO

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2011-07-01

22406 / 1

Active Ingredient

RIVAROXABAN

Application Number

22406

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2011-07-01

Regulatory Status

RX

2011
04 Nov
RX Application: 22406

Drug Name

XARELTO

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2011-11-04

22406 / 2

Active Ingredient

RIVAROXABAN

Application Number

22406

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2011-11-04

Regulatory Status

RX

2011
04 Nov
RX Application: 22406

Drug Name

XARELTO

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2011-11-04

22406 / 3

Active Ingredient

RIVAROXABAN

Application Number

22406

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2011-11-04

Regulatory Status

RX

2018
11 Oct
RX Application: 22406

Drug Name

XARELTO

Product Number

4

Dosage Form

-

Strength

2.5MG

Approval Date

2018-10-11

22406 / 4

Active Ingredient

RIVAROXABAN

Application Number

22406

Product Number

4

Dosage Form

-

Strength

2.5MG

Approval Date

2018-10-11

Regulatory Status

RX

2021
20 Dec
RX Application: 215859

Drug Name

XARELTO

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2021-12-20

215859 / 1

Active Ingredient

RIVAROXABAN

Application Number

215859

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2021-12-20

Regulatory Status

RX

2015
23 Oct
RX Application: 207953

Drug Name

YONDELIS

Product Number

1

Dosage Form

-

Strength

1MG/VIAL

Approval Date

2015-10-23

207953 / 1

Active Ingredient

TRABECTEDIN

Application Number

207953

Product Number

1

Dosage Form

-

Strength

1MG/VIAL

Approval Date

2015-10-23

Regulatory Status

RX

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Drug Status Breakdown
65 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

CONCERTA

Application Number

21121

Product Number

1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Dosage Form

-

Strength

18MG

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

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