Johnson & Johnson Innovative Medicine
FDA Approved Drugs

Johnson & Johnson Innovative Medicine

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 154
  • Latest Approval Date Feb 27, 2026
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
154
View
Unclassified
6
View
Discontinued
83
View
RX
65
View
Company Overview

Company

Johnson & Johnson Innovative Medicine

Country

U.S.A

Website

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Company Snapshot

Johnson & Johnson Innovative Medicine

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 ( 154 records )
2001
07 May
Discontinued Application: 21001

Drug Name

AXERT

Product Number

1

Dosage Form

-

Strength

EQ 6.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-05-07

21001 / 1

Active Ingredient

ALMOTRIPTAN MALATE

Application Number

21001

Product Number

1

Dosage Form

-

Strength

EQ 6.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-05-07

Regulatory Status

Discontinued

2001
07 May
Discontinued Application: 21001

Drug Name

AXERT

Product Number

2

Dosage Form

-

Strength

EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-05-07

21001 / 2

Active Ingredient

ALMOTRIPTAN MALATE

Application Number

21001

Product Number

2

Dosage Form

-

Strength

EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-05-07

Regulatory Status

Discontinued

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

1982
01 Jan
Discontinued Application: 17577

Drug Name

DITROPAN

Product Number

1

Dosage Form

-

Strength

5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17577 / 1

Active Ingredient

OXYBUTYNIN CHLORIDE

Application Number

17577

Product Number

1

Dosage Form

-

Strength

5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1998
16 Dec
Discontinued Application: 20897

Drug Name

DITROPAN XL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1998-12-16

20897 / 1

Active Ingredient

OXYBUTYNIN CHLORIDE

Application Number

20897

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1998-12-16

Regulatory Status

Discontinued

1998
16 Dec
Discontinued Application: 20897

Drug Name

DITROPAN XL

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1998-12-16

20897 / 2

Active Ingredient

OXYBUTYNIN CHLORIDE

Application Number

20897

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1998-12-16

Regulatory Status

Discontinued

1999
22 Jun
Discontinued Application: 20897

Drug Name

DITROPAN XL

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1999-06-22

20897 / 3

Active Ingredient

OXYBUTYNIN CHLORIDE

Application Number

20897

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1999-06-22

Regulatory Status

Discontinued

1990
07 Aug
Discontinued Application: 19813

Drug Name

DURAGESIC-100

Product Number

1

Dosage Form

-

Strength

100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1990-08-07

19813 / 1

Active Ingredient

FENTANYL

Application Number

19813

Product Number

1

Dosage Form

-

Strength

100MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1990-08-07

Regulatory Status

Discontinued

2005
04 Feb
Discontinued Application: 19813

Drug Name

DURAGESIC-12

Product Number

5

Dosage Form

-

Strength

12.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-02-04

19813 / 5

Active Ingredient

FENTANYL

Application Number

19813

Product Number

5

Dosage Form

-

Strength

12.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-02-04

Regulatory Status

Discontinued

1990
07 Aug
Discontinued Application: 19813

Drug Name

DURAGESIC-25

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1990-08-07

19813 / 4

Active Ingredient

FENTANYL

Application Number

19813

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1990-08-07

Regulatory Status

Discontinued

2018
24 Jan
Discontinued Application: 19813

Drug Name

DURAGESIC-37

Product Number

6

Dosage Form

-

Strength

37.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2018-01-24

19813 / 6

Active Ingredient

FENTANYL

Application Number

19813

Product Number

6

Dosage Form

-

Strength

37.5MCG/HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2018-01-24

Regulatory Status

Discontinued

1990
07 Aug
Discontinued Application: 19813

Drug Name

DURAGESIC-50

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1990-08-07

19813 / 3

Active Ingredient

FENTANYL

Application Number

19813

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1990-08-07

Regulatory Status

Discontinued

1990
07 Aug
Discontinued Application: 19813

Drug Name

DURAGESIC-75

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1990-08-07

19813 / 2

Active Ingredient

FENTANYL

Application Number

19813

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1990-08-07

Regulatory Status

Discontinued

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

1990
28 Dec
Discontinued Application: 19735

Drug Name

FLOXIN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1990-12-28

19735 / 1

Active Ingredient

OFLOXACIN

Application Number

19735

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1990-12-28

Regulatory Status

Discontinued

1990
28 Dec
Discontinued Application: 19735

Drug Name

FLOXIN

Product Number

2

Dosage Form

-

Strength

300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1990-12-28

19735 / 2

Active Ingredient

OFLOXACIN

Application Number

19735

Product Number

2

Dosage Form

-

Strength

300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1990-12-28

Regulatory Status

Discontinued

1990
28 Dec
Discontinued Application: 19735

Drug Name

FLOXIN

Product Number

3

Dosage Form

-

Strength

400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1990-12-28

19735 / 3

Active Ingredient

OFLOXACIN

Application Number

19735

Product Number

3

Dosage Form

-

Strength

400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1990-12-28

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 15923

Drug Name

HALDOL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

15923 / 1

Active Ingredient

HALOPERIDOL LACTATE

Application Number

15923

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1986
14 Jan
Discontinued Application: 18701

Drug Name

HALDOL

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

1986-01-14

18701 / 1

Active Ingredient

HALOPERIDOL DECANOATE

Application Number

18701

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

1986-01-14

Regulatory Status

Discontinued

1997
31 Jan
Discontinued Application: 18701

Drug Name

HALDOL

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

1997-01-31

18701 / 2

Active Ingredient

HALOPERIDOL DECANOATE

Application Number

18701

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

1997-01-31

Regulatory Status

Discontinued

1984
31 Jul
Discontinued Application: 19037

Drug Name

IMODIUM

Product Number

1

Dosage Form

-

Strength

1MG/5ML

Approval Date

1984-07-31

19037 / 1

Active Ingredient

LOPERAMIDE HYDROCHLORIDE

Application Number

19037

Product Number

1

Dosage Form

-

Strength

1MG/5ML

Approval Date

1984-07-31

Regulatory Status

Discontinued

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

2006
19 Dec
Discontinued Application: 21999

Drug Name

INVEGA

Product Number

4

Dosage Form

-

Strength

12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2006-12-19

21999 / 4

Active Ingredient

PALIPERIDONE

Application Number

21999

Product Number

4

Dosage Form

-

Strength

12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2006-12-19

Regulatory Status

Discontinued

2008
26 Aug
Discontinued Application: 21999

Drug Name

INVEGA

Product Number

6

Dosage Form

-

Strength

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

Approval Date

2008-08-26

21999 / 6

Active Ingredient

PALIPERIDONE

Application Number

21999

Product Number

6

Dosage Form

-

Strength

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

Approval Date

2008-08-26

Regulatory Status

Discontinued

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

1993
26 Feb
Discontinued Application: 20229

Drug Name

LEUSTATIN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1993-02-26

20229 / 1

Active Ingredient

CLADRIBINE

Application Number

20229

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1993-02-26

Regulatory Status

Discontinued

1996
20 Dec
Discontinued Application: 20634

Drug Name

LEVAQUIN

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1996-12-20

20634 / 1

Active Ingredient

LEVOFLOXACIN

Application Number

20634

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1996-12-20

Regulatory Status

Discontinued

1996
20 Dec
Discontinued Application: 20634

Drug Name

LEVAQUIN

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1996-12-20

20634 / 2

Active Ingredient

LEVOFLOXACIN

Application Number

20634

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1996-12-20

Regulatory Status

Discontinued

2000
08 Sep
Discontinued Application: 20634

Drug Name

LEVAQUIN

Product Number

3

Dosage Form

-

Strength

750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-09-08

20634 / 3

Active Ingredient

LEVOFLOXACIN

Application Number

20634

Product Number

3

Dosage Form

-

Strength

750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2000-09-08

Regulatory Status

Discontinued

1996
20 Dec
Discontinued Application: 20635

Drug Name

LEVAQUIN

Product Number

1

Dosage Form

-

Strength

EQ 500MG/20ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-12-20

20635 / 1

Active Ingredient

LEVOFLOXACIN

Application Number

20635

Product Number

1

Dosage Form

-

Strength

EQ 500MG/20ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-12-20

Regulatory Status

Discontinued

1996
20 Dec
Discontinued Application: 20635

Drug Name

LEVAQUIN

Product Number

4

Dosage Form

-

Strength

EQ 750MG/30ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-12-20

20635 / 4

Active Ingredient

LEVOFLOXACIN

Application Number

20635

Product Number

4

Dosage Form

-

Strength

EQ 750MG/30ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-12-20

Regulatory Status

Discontinued

2004
21 Oct
Discontinued Application: 21721

Drug Name

LEVAQUIN

Product Number

1

Dosage Form

-

Strength

250MG/10ML

Approval Date

2004-10-21

21721 / 1

Active Ingredient

LEVOFLOXACIN

Application Number

21721

Product Number

1

Dosage Form

-

Strength

250MG/10ML

Approval Date

2004-10-21

Regulatory Status

Discontinued

1996
20 Dec
Discontinued Application: 20635

Drug Name

LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

EQ 250MG/50ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-12-20

20635 / 2

Active Ingredient

LEVOFLOXACIN

Application Number

20635

Product Number

2

Dosage Form

-

Strength

EQ 250MG/50ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-12-20

Regulatory Status

Discontinued

1996
20 Dec
Discontinued Application: 20635

Drug Name

LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

EQ 500MG/100ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-12-20

20635 / 3

Active Ingredient

LEVOFLOXACIN

Application Number

20635

Product Number

3

Dosage Form

-

Strength

EQ 500MG/100ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-12-20

Regulatory Status

Discontinued

1996
20 Dec
Discontinued Application: 20635

Drug Name

LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

5

Dosage Form

-

Strength

EQ 750MG/150ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-12-20

20635 / 5

Active Ingredient

LEVOFLOXACIN

Application Number

20635

Product Number

5

Dosage Form

-

Strength

EQ 750MG/150ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1996-12-20

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16954

Drug Name

MICRONOR

Product Number

1

Dosage Form

-

Strength

0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

16954 / 1

Active Ingredient

NORETHINDRONE

Application Number

16954

Product Number

1

Dosage Form

-

Strength

0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17735

Drug Name

MODICON 28

Product Number

1

Dosage Form

-

Strength

0.035MG;0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17735 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE

Application Number

17735

Product Number

1

Dosage Form

-

Strength

0.035MG;0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 18533

Drug Name

NIZORAL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

18533 / 1

Active Ingredient

KETOCONAZOLE

Application Number

18533

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

1990
31 Aug
Discontinued Application: 19927

Drug Name

NIZORAL

Product Number

1

Dosage Form

-

Strength

2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1990-08-31

19927 / 1

Active Ingredient

KETOCONAZOLE

Application Number

19927

Product Number

1

Dosage Form

-

Strength

2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1990-08-31

Regulatory Status

Discontinued

2013
22 Nov
Discontinued Application: 205123

Drug Name

OLYSIO

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2013-11-22

205123 / 1

Active Ingredient

SIMEPREVIR SODIUM

Application Number

205123

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2013-11-22

Regulatory Status

Discontinued

1989
29 Dec
Discontinued Application: 19653

Drug Name

ORTHO CYCLEN-21

Product Number

1

Dosage Form

-

Strength

0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1989-12-29

19653 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORGESTIMATE

Application Number

19653

Product Number

1

Dosage Form

-

Strength

0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1989-12-29

Regulatory Status

Discontinued

1989
29 Dec
Discontinued Application: 19653

Drug Name

ORTHO CYCLEN-28

Product Number

2

Dosage Form

-

Strength

0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1989-12-29

19653 / 2

Active Ingredient

ETHINYL ESTRADIOL; NORGESTIMATE

Application Number

19653

Product Number

2

Dosage Form

-

Strength

0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1989-12-29

Regulatory Status

Discontinued

2001
20 Nov
Discontinued Application: 21180

Drug Name

ORTHO EVRA

Product Number

1

Dosage Form

-

Strength

0.035MG/24HR;0.15MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-11-20

21180 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORELGESTROMIN

Application Number

21180

Product Number

1

Dosage Form

-

Strength

0.035MG/24HR;0.15MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-11-20

Regulatory Status

Discontinued

1992
03 Jul
Discontinued Application: 19697

Drug Name

ORTHO TRI-CYCLEN

Product Number

1

Dosage Form

-

Strength

0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-07-03

19697 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORGESTIMATE

Application Number

19697

Product Number

1

Dosage Form

-

Strength

0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-07-03

Regulatory Status

Discontinued

1992
03 Jul
Discontinued Application: 19697

Drug Name

ORTHO TRI-CYCLEN

Product Number

2

Dosage Form

-

Strength

0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-07-03

19697 / 2

Active Ingredient

ETHINYL ESTRADIOL; NORGESTIMATE

Application Number

19697

Product Number

2

Dosage Form

-

Strength

0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-07-03

Regulatory Status

Discontinued

2002
22 Aug
Discontinued Application: 21241

Drug Name

ORTHO TRI-CYCLEN LO

Product Number

1

Dosage Form

-

Strength

0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2002-08-22

21241 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORGESTIMATE

Application Number

21241

Product Number

1

Dosage Form

-

Strength

0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2002-08-22

Regulatory Status

Discontinued

1992
14 Dec
Discontinued Application: 20301

Drug Name

ORTHO-CEPT

Product Number

1

Dosage Form

-

Strength

0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-12-14

20301 / 1

Active Ingredient

DESOGESTREL; ETHINYL ESTRADIOL

Application Number

20301

Product Number

1

Dosage Form

-

Strength

0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-12-14

Regulatory Status

Discontinued

1992
14 Dec
Discontinued Application: 20301

Drug Name

ORTHO-CEPT

Product Number

2

Dosage Form

-

Strength

0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-12-14

20301 / 2

Active Ingredient

DESOGESTREL; ETHINYL ESTRADIOL

Application Number

20301

Product Number

2

Dosage Form

-

Strength

0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1992-12-14

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17919

Drug Name

ORTHO-NOVUM 1/35-28

Product Number

2

Dosage Form

-

Strength

0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17919 / 2

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE

Application Number

17919

Product Number

2

Dosage Form

-

Strength

0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
04 Apr
Discontinued Application: 18985

Drug Name

ORTHO-NOVUM 7/7/7-21

Product Number

1

Dosage Form

-

Strength

0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG

Approval Date

1984-04-04

18985 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE

Application Number

18985

Product Number

1

Dosage Form

-

Strength

0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG

Approval Date

1984-04-04

Regulatory Status

Discontinued

1984
04 Apr
Discontinued Application: 18985

Drug Name

ORTHO-NOVUM 7/7/7-28

Product Number

2

Dosage Form

-

Strength

0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-04-04

18985 / 2

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE

Application Number

18985

Product Number

2

Dosage Form

-

Strength

0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-04-04

Regulatory Status

Discontinued

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

-
Unclassified Application: 220092

Drug Name

PREZCOBIX

Product Number

2

Dosage Form

-

Strength

675MG/150MG

Approval Date

-

220092 / 2

Active Ingredient

DARUNAVIR AND COBICISTAT

Application Number

220092

Product Number

2

Dosage Form

-

Strength

675MG/150MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 220092

Drug Name

PREZCOBIX

Product Number

3

Dosage Form

-

Strength

600MG/90MG

Approval Date

-

220092 / 3

Active Ingredient

DARUNAVIR AND COBICISTAT

Application Number

220092

Product Number

3

Dosage Form

-

Strength

600MG/90MG

Approval Date

-

Regulatory Status

Unclassified

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

2006
23 Jun
Discontinued Application: 21976

Drug Name

PREZISTA

Product Number

1

Dosage Form

-

Strength

300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2006-06-23

21976 / 1

Active Ingredient

DARUNAVIR

Application Number

21976

Product Number

1

Dosage Form

-

Strength

300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2006-06-23

Regulatory Status

Discontinued

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
21 Oct
Discontinued Application: 21976

Drug Name

PREZISTA

Product Number

3

Dosage Form

-

Strength

400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2008-10-21

21976 / 3

Active Ingredient

DARUNAVIR

Application Number

21976

Product Number

3

Dosage Form

-

Strength

400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2008-10-21

Regulatory Status

Discontinued

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 Jul
Discontinued Application: 20210

Drug Name

PROPULSID

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1993-07-29

20210 / 1

Active Ingredient

CISAPRIDE MONOHYDRATE

Application Number

20210

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1993-07-29

Regulatory Status

Discontinued

1993
23 Dec
Discontinued Application: 20210

Drug Name

PROPULSID

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

1993-12-23

20210 / 2

Active Ingredient

CISAPRIDE MONOHYDRATE

Application Number

20210

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

1993-12-23

Regulatory Status

Discontinued

1995
15 Sep
Discontinued Application: 20398

Drug Name

PROPULSID

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

1995-09-15

20398 / 1

Active Ingredient

CISAPRIDE MONOHYDRATE

Application Number

20398

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML

Approval Date

1995-09-15

Regulatory Status

Discontinued

2001
28 Feb
Discontinued Application: 21169

Drug Name

RAZADYNE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-02-28

21169 / 1

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

21169

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-02-28

Regulatory Status

Discontinued

2001
28 Feb
Discontinued Application: 21169

Drug Name

RAZADYNE

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-02-28

21169 / 2

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

21169

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-02-28

Regulatory Status

Discontinued

2001
28 Feb
Discontinued Application: 21169

Drug Name

RAZADYNE

Product Number

3

Dosage Form

-

Strength

EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-02-28

21169 / 3

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

21169

Product Number

3

Dosage Form

-

Strength

EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-02-28

Regulatory Status

Discontinued

2001
22 Jun
Discontinued Application: 21224

Drug Name

RAZADYNE

Product Number

1

Dosage Form

-

Strength

4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-06-22

21224 / 1

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

21224

Product Number

1

Dosage Form

-

Strength

4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-06-22

Regulatory Status

Discontinued

2005
01 Apr
Discontinued Application: 21615

Drug Name

RAZADYNE ER

Product Number

1

Dosage Form

-

Strength

EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-04-01

21615 / 1

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

21615

Product Number

1

Dosage Form

-

Strength

EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-04-01

Regulatory Status

Discontinued

2005
01 Apr
Discontinued Application: 21615

Drug Name

RAZADYNE ER

Product Number

2

Dosage Form

-

Strength

EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-04-01

21615 / 2

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

21615

Product Number

2

Dosage Form

-

Strength

EQ 16MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-04-01

Regulatory Status

Discontinued

2005
01 Apr
Discontinued Application: 21615

Drug Name

RAZADYNE ER

Product Number

3

Dosage Form

-

Strength

EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-04-01

21615 / 3

Active Ingredient

GALANTAMINE HYDROBROMIDE

Application Number

21615

Product Number

3

Dosage Form

-

Strength

EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-04-01

Regulatory Status

Discontinued

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

1993
29 Dec
Discontinued Application: 20272

Drug Name

RISPERDAL

Product Number

5

Dosage Form

-

Strength

5MG

Approval Date

1993-12-29

20272 / 5

Active Ingredient

RISPERIDONE

Application Number

20272

Product Number

5

Dosage Form

-

Strength

5MG

Approval Date

1993-12-29

Regulatory Status

Discontinued

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
02 Apr
Discontinued Application: 21444

Drug Name

RISPERDAL

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2003-04-02

21444 / 1

Active Ingredient

RISPERIDONE

Application Number

21444

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2003-04-02

Regulatory Status

Discontinued

2003
02 Apr
Discontinued Application: 21444

Drug Name

RISPERDAL

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2003-04-02

21444 / 2

Active Ingredient

RISPERIDONE

Application Number

21444

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2003-04-02

Regulatory Status

Discontinued

2003
02 Apr
Discontinued Application: 21444

Drug Name

RISPERDAL

Product Number

3

Dosage Form

-

Strength

2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-04-02

21444 / 3

Active Ingredient

RISPERIDONE

Application Number

21444

Product Number

3

Dosage Form

-

Strength

2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-04-02

Regulatory Status

Discontinued

2004
23 Dec
Discontinued Application: 21444

Drug Name

RISPERDAL

Product Number

4

Dosage Form

-

Strength

3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2004-12-23

21444 / 4

Active Ingredient

RISPERIDONE

Application Number

21444

Product Number

4

Dosage Form

-

Strength

3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2004-12-23

Regulatory Status

Discontinued

2004
23 Dec
Discontinued Application: 21444

Drug Name

RISPERDAL

Product Number

5

Dosage Form

-

Strength

4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2004-12-23

21444 / 5

Active Ingredient

RISPERIDONE

Application Number

21444

Product Number

5

Dosage Form

-

Strength

4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2004-12-23

Regulatory Status

Discontinued

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

1997
21 Feb
Discontinued Application: 20657

Drug Name

SPORANOX

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1997-02-21

20657 / 1

Active Ingredient

ITRACONAZOLE

Application Number

20657

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1997-02-21

Regulatory Status

Discontinued

1999
30 Mar
Discontinued Application: 20966

Drug Name

SPORANOX

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1999-03-30

20966 / 1

Active Ingredient

ITRACONAZOLE

Application Number

20966

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1999-03-30

Regulatory Status

Discontinued

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

1988
24 May
Discontinued Application: 19641

Drug Name

TERAZOL 3

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1988-05-24

19641 / 1

Active Ingredient

TERCONAZOLE

Application Number

19641

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1988-05-24

Regulatory Status

Discontinued

1991
21 Feb
Discontinued Application: 19964

Drug Name

TERAZOL 3

Product Number

1

Dosage Form

-

Strength

0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1991-02-21

19964 / 1

Active Ingredient

TERCONAZOLE

Application Number

19964

Product Number

1

Dosage Form

-

Strength

0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1991-02-21

Regulatory Status

Discontinued

1987
31 Dec
Discontinued Application: 19579

Drug Name

TERAZOL 7

Product Number

1

Dosage Form

-

Strength

0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-12-31

19579 / 1

Active Ingredient

TERCONAZOLE

Application Number

19579

Product Number

1

Dosage Form

-

Strength

0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1987-12-31

Regulatory Status

Discontinued

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
Discontinued Application: 20505

Drug Name

TOPAMAX

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

1996-12-24

20505 / 3

Active Ingredient

TOPIRAMATE

Application Number

20505

Product Number

3

Dosage Form

-

Strength

300MG

Approval Date

1996-12-24

Regulatory Status

Discontinued

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

1996
24 Dec
Discontinued Application: 20505

Drug Name

TOPAMAX

Product Number

6

Dosage Form

-

Strength

400MG

Approval Date

1996-12-24

20505 / 6

Active Ingredient

TOPIRAMATE

Application Number

20505

Product Number

6

Dosage Form

-

Strength

400MG

Approval Date

1996-12-24

Regulatory Status

Discontinued

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

1998
26 Oct
Discontinued Application: 20844

Drug Name

TOPAMAX SPRINKLE

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1998-10-26

20844 / 3

Active Ingredient

TOPIRAMATE

Application Number

20844

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1998-10-26

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85055

Drug Name

TYLENOL W/ CODEINE NO. 1

Product Number

1

Dosage Form

-

Strength

300MG;7.5MG

Approval Date

1982-01-01

85055 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

85055

Product Number

1

Dosage Form

-

Strength

300MG;7.5MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85055

Drug Name

TYLENOL W/ CODEINE NO. 2

Product Number

2

Dosage Form

-

Strength

300MG;15MG

Approval Date

1982-01-01

85055 / 2

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

85055

Product Number

2

Dosage Form

-

Strength

300MG;15MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85055

Drug Name

TYLENOL W/ CODEINE NO. 3

Product Number

3

Dosage Form

-

Strength

300MG;30MG

Approval Date

1982-01-01

85055 / 3

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

85055

Product Number

3

Dosage Form

-

Strength

300MG;30MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85055

Drug Name

TYLENOL W/ CODEINE NO. 4

Product Number

4

Dosage Form

-

Strength

300MG;60MG

Approval Date

1982-01-01

85055 / 4

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

85055

Product Number

4

Dosage Form

-

Strength

300MG;60MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
12 Dec
Discontinued Application: 88790

Drug Name

TYLOX

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

1984-12-12

88790 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

88790

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

1984-12-12

Regulatory Status

Discontinued

2001
15 Aug
Discontinued Application: 21123

Drug Name

ULTRACET

Product Number

1

Dosage Form

-

Strength

325MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-08-15

21123 / 1

Active Ingredient

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Application Number

21123

Product Number

1

Dosage Form

-

Strength

325MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2001-08-15

Regulatory Status

Discontinued

1995
03 Mar
Discontinued Application: 20281

Drug Name

ULTRAM

Product Number

1

Dosage Form

-

Strength

100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1995-03-03

20281 / 1

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

20281

Product Number

1

Dosage Form

-

Strength

100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1995-03-03

Regulatory Status

Discontinued

1995
03 Mar
Discontinued Application: 20281

Drug Name

ULTRAM

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1995-03-03

20281 / 2

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

20281

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1995-03-03

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17481

Drug Name

VERMOX

Product Number

1

Dosage Form

-

Strength

100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17481 / 1

Active Ingredient

MEBENDAZOLE

Application Number

17481

Product Number

1

Dosage Form

-

Strength

100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

2016
19 Oct
Discontinued Application: 208398

Drug Name

VERMOX

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2016-10-19

208398 / 1

Active Ingredient

MEBENDAZOLE

Application Number

208398

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2016-10-19

Regulatory Status

Discontinued

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

-
Unclassified Application: 202439

Drug Name

XARELTO

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

-

202439 / 1

Active Ingredient

RIVAROXABAN

Application Number

202439

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 202439

Drug Name

XARELTO

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

-

202439 / 2

Active Ingredient

RIVAROXABAN

Application Number

202439

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 202439

Drug Name

XARELTO

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

-

202439 / 3

Active Ingredient

RIVAROXABAN

Application Number

202439

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 202439

Drug Name

XARELTO

Product Number

4

Dosage Form

-

Strength

2.5MG

Approval Date

-

202439 / 4

Active Ingredient

RIVAROXABAN

Application Number

202439

Product Number

4

Dosage Form

-

Strength

2.5MG

Approval Date

-

Regulatory Status

Unclassified

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
154 total
  • Discontinued
  • RX
  • Unclassified
Official Source

FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.

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Explore important FDA approved drug information available in the records above.

Drug Name

AXERT

Application Number

21001

Product Number

1

Active Ingredient

ALMOTRIPTAN MALATE

Dosage Form

-

Strength

EQ 6.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

FDA Approved Drug Data

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