Amneal Pharmaceuticals RX
FDA Approved Drugs

Amneal Pharmaceuticals 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 96
  • Latest Approval Date Jun 14, 2017
  • Data Source FDA
  • First Approval Date Aug 25, 2009
All
120
View
Discontinued
21
View
OTC
3
View
RX
96
View
Company Overview

Company

Amneal Pharmaceuticals RX

Country

U.S.A

Website

Visit Website

Email

nfo@rakspharma.com

Social Profiles

Company Snapshot

Amneal Pharmaceuticals RX

400 Crossing Boulevard, 3rd Floor Bridgewater, New Jersey 08807

U.S.A

amneal.com/ nfo@rakspharma.com View on Map
FDA Approved Drug Records ( 96 records )
2014
18 Jun
RX Application: 204605

Drug Name

ACYCLOVIR

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2014-06-18

204605 / 1

Active Ingredient

ACYCLOVIR

Application Number

204605

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2014-06-18

Regulatory Status

RX

2010
12 May
RX Application: 79241

Drug Name

ALBUTEROL SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/5ML

Approval Date

2010-05-12

79241 / 1

Active Ingredient

ALBUTEROL SULFATE

Application Number

79241

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/5ML

Approval Date

2010-05-12

Regulatory Status

RX

2015
14 Aug
RX Application: 203906

Drug Name

ARIPIPRAZOLE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2015-08-14

203906 / 1

Active Ingredient

ARIPIPRAZOLE

Application Number

203906

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2015-08-14

Regulatory Status

RX

2016
17 Jun
RX Application: 204838

Drug Name

ARIPIPRAZOLE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2016-06-17

204838 / 1

Active Ingredient

ARIPIPRAZOLE

Application Number

204838

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2016-06-17

Regulatory Status

RX

2016
17 Jun
RX Application: 204838

Drug Name

ARIPIPRAZOLE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2016-06-17

204838 / 2

Active Ingredient

ARIPIPRAZOLE

Application Number

204838

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2016-06-17

Regulatory Status

RX

2016
17 Jun
RX Application: 204838

Drug Name

ARIPIPRAZOLE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2016-06-17

204838 / 3

Active Ingredient

ARIPIPRAZOLE

Application Number

204838

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2016-06-17

Regulatory Status

RX

2016
17 Jun
RX Application: 204838

Drug Name

ARIPIPRAZOLE

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2016-06-17

204838 / 4

Active Ingredient

ARIPIPRAZOLE

Application Number

204838

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2016-06-17

Regulatory Status

RX

2016
17 Jun
RX Application: 204838

Drug Name

ARIPIPRAZOLE

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2016-06-17

204838 / 5

Active Ingredient

ARIPIPRAZOLE

Application Number

204838

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2016-06-17

Regulatory Status

RX

2016
17 Jun
RX Application: 204838

Drug Name

ARIPIPRAZOLE

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2016-06-17

204838 / 6

Active Ingredient

ARIPIPRAZOLE

Application Number

204838

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2016-06-17

Regulatory Status

RX

2014
18 Mar
RX Application: 202960

Drug Name

ATOVAQUONE

Product Number

1

Dosage Form

-

Strength

750MG/5ML

Approval Date

2014-03-18

202960 / 1

Active Ingredient

ATOVAQUONE

Application Number

202960

Product Number

1

Dosage Form

-

Strength

750MG/5ML

Approval Date

2014-03-18

Regulatory Status

RX

2017
14 Jun
RX Application: 203289

Drug Name

CALCITRIOL

Product Number

1

Dosage Form

-

Strength

0.5MCG

Approval Date

2017-06-14

203289 / 1

Active Ingredient

CALCITRIOL

Application Number

203289

Product Number

1

Dosage Form

-

Strength

0.5MCG

Approval Date

2017-06-14

Regulatory Status

RX

2017
14 Jun
RX Application: 203289

Drug Name

CALCITRIOL

Product Number

2

Dosage Form

-

Strength

0.25MCG

Approval Date

2017-06-14

203289 / 2

Active Ingredient

CALCITRIOL

Application Number

203289

Product Number

2

Dosage Form

-

Strength

0.25MCG

Approval Date

2017-06-14

Regulatory Status

RX

2009
07 Oct
RX Application: 90766

Drug Name

CETIRIZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2009-10-07

90766 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

90766

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2009-10-07

Regulatory Status

RX

2014
11 Apr
RX Application: 203751

Drug Name

CLOPIDOGREL BISULFATE

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2014-04-11

203751 / 1

Active Ingredient

CLOPIDOGREL BISULFATE

Application Number

203751

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2014-04-11

Regulatory Status

RX

2016
28 Sep
RX Application: 204711

Drug Name

COLCHICINE

Product Number

1

Dosage Form

-

Strength

0.6MG

Approval Date

2016-09-28

204711 / 1

Active Ingredient

COLCHICINE

Application Number

204711

Product Number

1

Dosage Form

-

Strength

0.6MG

Approval Date

2016-09-28

Regulatory Status

RX

2016
02 Sep
RX Application: 206116

Drug Name

DICLOFENAC SODIUM

Product Number

1

Dosage Form

-

Strength

1.5%

Approval Date

2016-09-02

206116 / 1

Active Ingredient

DICLOFENAC SODIUM

Application Number

206116

Product Number

1

Dosage Form

-

Strength

1.5%

Approval Date

2016-09-02

Regulatory Status

RX

2016
25 Nov
RX Application: 203995

Drug Name

DICLOFENAC SODIUM AND MISOPROSTOL

Product Number

1

Dosage Form

-

Strength

50MG;0.2MG

Approval Date

2016-11-25

203995 / 1

Active Ingredient

DICLOFENAC SODIUM; MISOPROSTOL

Application Number

203995

Product Number

1

Dosage Form

-

Strength

50MG;0.2MG

Approval Date

2016-11-25

Regulatory Status

RX

2016
25 Nov
RX Application: 203995

Drug Name

DICLOFENAC SODIUM AND MISOPROSTOL

Product Number

2

Dosage Form

-

Strength

75MG;0.2MG

Approval Date

2016-11-25

203995 / 2

Active Ingredient

DICLOFENAC SODIUM; MISOPROSTOL

Application Number

203995

Product Number

2

Dosage Form

-

Strength

75MG;0.2MG

Approval Date

2016-11-25

Regulatory Status

RX

2015
29 May
RX Application: 203730

Drug Name

DIVALPROEX SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 250MG VALPROIC ACID

Approval Date

2015-05-29

203730 / 1

Active Ingredient

DIVALPROEX SODIUM

Application Number

203730

Product Number

1

Dosage Form

-

Strength

EQ 250MG VALPROIC ACID

Approval Date

2015-05-29

Regulatory Status

RX

2015
29 May
RX Application: 203730

Drug Name

DIVALPROEX SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG VALPROIC ACID

Approval Date

2015-05-29

203730 / 2

Active Ingredient

DIVALPROEX SODIUM

Application Number

203730

Product Number

2

Dosage Form

-

Strength

EQ 500MG VALPROIC ACID

Approval Date

2015-05-29

Regulatory Status

RX

2015
12 Nov
RX Application: 206652

Drug Name

ENTECAVIR

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2015-11-12

206652 / 1

Active Ingredient

ENTECAVIR

Application Number

206652

Product Number

1

Dosage Form

-

Strength

0.5MG

Approval Date

2015-11-12

Regulatory Status

RX

2015
12 Nov
RX Application: 206652

Drug Name

ENTECAVIR

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2015-11-12

206652 / 2

Active Ingredient

ENTECAVIR

Application Number

206652

Product Number

2

Dosage Form

-

Strength

1MG

Approval Date

2015-11-12

Regulatory Status

RX

2012
14 Mar
RX Application: 202227

Drug Name

ESCITALOPRAM OXALATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/5ML

Approval Date

2012-03-14

202227 / 1

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

202227

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/5ML

Approval Date

2012-03-14

Regulatory Status

RX

2017
17 May
RX Application: 205619

Drug Name

ESCITALOPRAM OXALATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2017-05-17

205619 / 1

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

205619

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2017-05-17

Regulatory Status

RX

2017
17 May
RX Application: 205619

Drug Name

ESCITALOPRAM OXALATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2017-05-17

205619 / 2

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

205619

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2017-05-17

Regulatory Status

RX

2017
17 May
RX Application: 205619

Drug Name

ESCITALOPRAM OXALATE

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2017-05-17

205619 / 3

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

205619

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2017-05-17

Regulatory Status

RX

2015
29 May
RX Application: 205256

Drug Name

ESTRADIOL

Product Number

1

Dosage Form

-

Strength

10MCG

Approval Date

2015-05-29

205256 / 1

Active Ingredient

ESTRADIOL

Application Number

205256

Product Number

1

Dosage Form

-

Strength

10MCG

Approval Date

2015-05-29

Regulatory Status

RX

2011
13 Sep
RX Application: 201680

Drug Name

FELBAMATE

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2011-09-13

201680 / 1

Active Ingredient

FELBAMATE

Application Number

201680

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2011-09-13

Regulatory Status

RX

2011
13 Sep
RX Application: 201680

Drug Name

FELBAMATE

Product Number

2

Dosage Form

-

Strength

600MG

Approval Date

2011-09-13

201680 / 2

Active Ingredient

FELBAMATE

Application Number

201680

Product Number

2

Dosage Form

-

Strength

600MG

Approval Date

2011-09-13

Regulatory Status

RX

2011
16 Dec
RX Application: 202385

Drug Name

FELBAMATE

Product Number

1

Dosage Form

-

Strength

600MG/5ML

Approval Date

2011-12-16

202385 / 1

Active Ingredient

FELBAMATE

Application Number

202385

Product Number

1

Dosage Form

-

Strength

600MG/5ML

Approval Date

2011-12-16

Regulatory Status

RX

2012
23 Mar
RX Application: 202024

Drug Name

GABAPENTIN

Product Number

1

Dosage Form

-

Strength

250MG/5ML

Approval Date

2012-03-23

202024 / 1

Active Ingredient

GABAPENTIN

Application Number

202024

Product Number

1

Dosage Form

-

Strength

250MG/5ML

Approval Date

2012-03-23

Regulatory Status

RX

2010
01 Dec
RX Application: 91549

Drug Name

INDOMETHACIN

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2010-12-01

91549 / 1

Active Ingredient

INDOMETHACIN

Application Number

91549

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2010-12-01

Regulatory Status

RX

2016
26 Sep
RX Application: 205080

Drug Name

ITRACONAZOLE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2016-09-26

205080 / 1

Active Ingredient

ITRACONAZOLE

Application Number

205080

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2016-09-26

Regulatory Status

RX

2015
30 Oct
RX Application: 205573

Drug Name

ITRACONAZOLE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2015-10-30

205573 / 1

Active Ingredient

ITRACONAZOLE

Application Number

205573

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2015-10-30

Regulatory Status

RX

2009
27 Oct
RX Application: 90992

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2009-10-27

90992 / 1

Active Ingredient

LEVETIRACETAM

Application Number

90992

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2009-10-27

Regulatory Status

RX

2015
07 Aug
RX Application: 206297

Drug Name

LIDOCAINE

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2015-08-07

206297 / 1

Active Ingredient

LIDOCAINE

Application Number

206297

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2015-08-07

Regulatory Status

RX

2009
23 Dec
RX Application: 91383

Drug Name

LORAZEPAM

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2009-12-23

91383 / 1

Active Ingredient

LORAZEPAM

Application Number

91383

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2009-12-23

Regulatory Status

RX

2016
12 Apr
RX Application: 205883

Drug Name

MEROPENEM

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2016-04-12

205883 / 1

Active Ingredient

MEROPENEM

Application Number

205883

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2016-04-12

Regulatory Status

RX

2016
12 Apr
RX Application: 205883

Drug Name

MEROPENEM

Product Number

2

Dosage Form

-

Strength

1GM/VIAL

Approval Date

2016-04-12

205883 / 2

Active Ingredient

MEROPENEM

Application Number

205883

Product Number

2

Dosage Form

-

Strength

1GM/VIAL

Approval Date

2016-04-12

Regulatory Status

RX

2013
21 Jun
RX Application: 203399

Drug Name

METAXALONE

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

2013-06-21

203399 / 1

Active Ingredient

METAXALONE

Application Number

203399

Product Number

1

Dosage Form

-

Strength

800MG

Approval Date

2013-06-21

Regulatory Status

RX

2016
22 Apr
RX Application: 205081

Drug Name

MILNACIPRAN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2016-04-22

205081 / 1

Active Ingredient

MILNACIPRAN HYDROCHLORIDE

Application Number

205081

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2016-04-22

Regulatory Status

RX

2016
22 Apr
RX Application: 205081

Drug Name

MILNACIPRAN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2016-04-22

205081 / 2

Active Ingredient

MILNACIPRAN HYDROCHLORIDE

Application Number

205081

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2016-04-22

Regulatory Status

RX

2016
22 Apr
RX Application: 205081

Drug Name

MILNACIPRAN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2016-04-22

205081 / 3

Active Ingredient

MILNACIPRAN HYDROCHLORIDE

Application Number

205081

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2016-04-22

Regulatory Status

RX

2016
22 Apr
RX Application: 205081

Drug Name

MILNACIPRAN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2016-04-22

205081 / 4

Active Ingredient

MILNACIPRAN HYDROCHLORIDE

Application Number

205081

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2016-04-22

Regulatory Status

RX

2017
03 Apr
RX Application: 207989

Drug Name

MOMETASONE FUROATE

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2017-04-03

207989 / 1

Active Ingredient

MOMETASONE FUROATE

Application Number

207989

Product Number

1

Dosage Form

-

Strength

0.05MG/SPRAY

Approval Date

2017-04-03

Regulatory Status

RX

2015
04 Sep
RX Application: 204604

Drug Name

MONTELUKAST SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2015-09-04

204604 / 1

Active Ingredient

MONTELUKAST SODIUM

Application Number

204604

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2015-09-04

Regulatory Status

RX

2015
24 Jul
RX Application: 203578

Drug Name

NIACIN

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2015-07-24

203578 / 1

Active Ingredient

NIACIN

Application Number

203578

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2015-07-24

Regulatory Status

RX

2015
24 Jul
RX Application: 203578

Drug Name

NIACIN

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2015-07-24

203578 / 2

Active Ingredient

NIACIN

Application Number

203578

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2015-07-24

Regulatory Status

RX

2015
11 Dec
RX Application: 204178

Drug Name

NIACIN

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

2015-12-11

204178 / 1

Active Ingredient

NIACIN

Application Number

204178

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

2015-12-11

Regulatory Status

RX

2012
30 Jul
RX Application: 200275

Drug Name

NORETHINDRONE ACETATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2012-07-30

200275 / 1

Active Ingredient

NORETHINDRONE ACETATE

Application Number

200275

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2012-07-30

Regulatory Status

RX

2011
31 Jan
RX Application: 91483

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/5ML

Approval Date

2011-01-31

91483 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

91483

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/5ML

Approval Date

2011-01-31

Regulatory Status

RX

2012
17 Sep
RX Application: 202961

Drug Name

OXCARBAZEPINE

Product Number

1

Dosage Form

-

Strength

300MG/5ML

Approval Date

2012-09-17

202961 / 1

Active Ingredient

OXCARBAZEPINE

Application Number

202961

Product Number

1

Dosage Form

-

Strength

300MG/5ML

Approval Date

2012-09-17

Regulatory Status

RX

2015
23 Nov
RX Application: 204010

Drug Name

OXYBUTYNIN CHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-11-23

204010 / 1

Active Ingredient

OXYBUTYNIN CHLORIDE

Application Number

204010

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-11-23

Regulatory Status

RX

2015
23 Nov
RX Application: 204010

Drug Name

OXYBUTYNIN CHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2015-11-23

204010 / 2

Active Ingredient

OXYBUTYNIN CHLORIDE

Application Number

204010

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2015-11-23

Regulatory Status

RX

2015
23 Nov
RX Application: 204010

Drug Name

OXYBUTYNIN CHLORIDE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2015-11-23

204010 / 3

Active Ingredient

OXYBUTYNIN CHLORIDE

Application Number

204010

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2015-11-23

Regulatory Status

RX

2014
03 Jun
RX Application: 203638

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2014-06-03

203638 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

203638

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2014-06-03

Regulatory Status

RX

2014
03 Jun
RX Application: 203638

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2014-06-03

203638 / 2

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

203638

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2014-06-03

Regulatory Status

RX

2014
03 Jun
RX Application: 203638

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2014-06-03

203638 / 3

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

203638

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2014-06-03

Regulatory Status

RX

2014
03 Jun
RX Application: 203638

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2014-06-03

203638 / 4

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

203638

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2014-06-03

Regulatory Status

RX

2014
03 Jun
RX Application: 203638

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

2014-06-03

203638 / 5

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

203638

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

2014-06-03

Regulatory Status

RX

2016
26 Jan
RX Application: 205119

Drug Name

PANTOPRAZOLE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2016-01-26

205119 / 1

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

205119

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2016-01-26

Regulatory Status

RX

2016
26 Jan
RX Application: 205119

Drug Name

PANTOPRAZOLE SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2016-01-26

205119 / 2

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

205119

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2016-01-26

Regulatory Status

RX

2013
22 Feb
RX Application: 202128

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

10MEQ

Approval Date

2013-02-22

202128 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

202128

Product Number

1

Dosage Form

-

Strength

10MEQ

Approval Date

2013-02-22

Regulatory Status

RX

2013
24 Apr
RX Application: 200894

Drug Name

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

10MG/5ML;6.25MG/5ML

Approval Date

2013-04-24

200894 / 1

Active Ingredient

CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

Application Number

200894

Product Number

1

Dosage Form

-

Strength

10MG/5ML;6.25MG/5ML

Approval Date

2013-04-24

Regulatory Status

RX

2011
08 Feb
RX Application: 90575

Drug Name

PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

15MG/5ML;6.25MG/5ML

Approval Date

2011-02-08

90575 / 1

Active Ingredient

DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE

Application Number

90575

Product Number

1

Dosage Form

-

Strength

15MG/5ML;6.25MG/5ML

Approval Date

2011-02-08

Regulatory Status

RX

2009
25 Aug
RX Application: 40902

Drug Name

PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/5ML;6.25MG/5ML

Approval Date

2009-08-25

40902 / 1

Active Ingredient

PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

Application Number

40902

Product Number

1

Dosage Form

-

Strength

5MG/5ML;6.25MG/5ML

Approval Date

2009-08-25

Regulatory Status

RX

2015
26 Aug
RX Application: 200963

Drug Name

PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

10MG/5ML;5MG/5ML;6.25MG/5ML

Approval Date

2015-08-26

200963 / 1

Active Ingredient

CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE

Application Number

200963

Product Number

1

Dosage Form

-

Strength

10MG/5ML;5MG/5ML;6.25MG/5ML

Approval Date

2015-08-26

Regulatory Status

RX

2015
15 Jul
RX Application: 203729

Drug Name

QUININE SULFATE

Product Number

1

Dosage Form

-

Strength

324MG

Approval Date

2015-07-15

203729 / 1

Active Ingredient

QUININE SULFATE

Application Number

203729

Product Number

1

Dosage Form

-

Strength

324MG

Approval Date

2015-07-15

Regulatory Status

RX

2015
31 Jul
RX Application: 204179

Drug Name

RABEPRAZOLE SODIUM

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2015-07-31

204179 / 1

Active Ingredient

RABEPRAZOLE SODIUM

Application Number

204179

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2015-07-31

Regulatory Status

RX

2016
08 Apr
RX Application: 208206

Drug Name

RALOXIFENE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2016-04-08

208206 / 1

Active Ingredient

RALOXIFENE HYDROCHLORIDE

Application Number

208206

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2016-04-08

Regulatory Status

RX

2011
25 May
RX Application: 91384

Drug Name

RISPERIDONE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2011-05-25

91384 / 1

Active Ingredient

RISPERIDONE

Application Number

91384

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2011-05-25

Regulatory Status

RX

2013
28 Feb
RX Application: 202025

Drug Name

SILDENAFIL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2013-02-28

202025 / 1

Active Ingredient

SILDENAFIL CITRATE

Application Number

202025

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2013-02-28

Regulatory Status

RX

2015
08 Sep
RX Application: 204415

Drug Name

TELMISARTAN

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2015-09-08

204415 / 1

Active Ingredient

TELMISARTAN

Application Number

204415

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2015-09-08

Regulatory Status

RX

2015
08 Sep
RX Application: 204415

Drug Name

TELMISARTAN

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2015-09-08

204415 / 2

Active Ingredient

TELMISARTAN

Application Number

204415

Product Number

2

Dosage Form

-

Strength

40MG

Approval Date

2015-09-08

Regulatory Status

RX

2015
08 Sep
RX Application: 204415

Drug Name

TELMISARTAN

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

2015-09-08

204415 / 3

Active Ingredient

TELMISARTAN

Application Number

204415

Product Number

3

Dosage Form

-

Strength

80MG

Approval Date

2015-09-08

Regulatory Status

RX

2016
23 May
RX Application: 203482

Drug Name

TEMAZEPAM

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2016-05-23

203482 / 1

Active Ingredient

TEMAZEPAM

Application Number

203482

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

2016-05-23

Regulatory Status

RX

2016
23 May
RX Application: 203482

Drug Name

TEMAZEPAM

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2016-05-23

203482 / 2

Active Ingredient

TEMAZEPAM

Application Number

203482

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2016-05-23

Regulatory Status

RX

2016
23 May
RX Application: 203482

Drug Name

TEMAZEPAM

Product Number

3

Dosage Form

-

Strength

22.5MG

Approval Date

2016-05-23

203482 / 3

Active Ingredient

TEMAZEPAM

Application Number

203482

Product Number

3

Dosage Form

-

Strength

22.5MG

Approval Date

2016-05-23

Regulatory Status

RX

2016
23 May
RX Application: 203482

Drug Name

TEMAZEPAM

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2016-05-23

203482 / 4

Active Ingredient

TEMAZEPAM

Application Number

203482

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2016-05-23

Regulatory Status

RX

2015
08 May
RX Application: 203691

Drug Name

TEMOZOLOMIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-05-08

203691 / 1

Active Ingredient

TEMOZOLOMIDE

Application Number

203691

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-05-08

Regulatory Status

RX

2015
08 May
RX Application: 203691

Drug Name

TEMOZOLOMIDE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2015-05-08

203691 / 2

Active Ingredient

TEMOZOLOMIDE

Application Number

203691

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2015-05-08

Regulatory Status

RX

2015
08 May
RX Application: 203691

Drug Name

TEMOZOLOMIDE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2015-05-08

203691 / 3

Active Ingredient

TEMOZOLOMIDE

Application Number

203691

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2015-05-08

Regulatory Status

RX

2015
08 May
RX Application: 203691

Drug Name

TEMOZOLOMIDE

Product Number

4

Dosage Form

-

Strength

140MG

Approval Date

2015-05-08

203691 / 4

Active Ingredient

TEMOZOLOMIDE

Application Number

203691

Product Number

4

Dosage Form

-

Strength

140MG

Approval Date

2015-05-08

Regulatory Status

RX

2015
08 May
RX Application: 203691

Drug Name

TEMOZOLOMIDE

Product Number

5

Dosage Form

-

Strength

180MG

Approval Date

2015-05-08

203691 / 5

Active Ingredient

TEMOZOLOMIDE

Application Number

203691

Product Number

5

Dosage Form

-

Strength

180MG

Approval Date

2015-05-08

Regulatory Status

RX

2015
08 May
RX Application: 203691

Drug Name

TEMOZOLOMIDE

Product Number

6

Dosage Form

-

Strength

250MG

Approval Date

2015-05-08

203691 / 6

Active Ingredient

TEMOZOLOMIDE

Application Number

203691

Product Number

6

Dosage Form

-

Strength

250MG

Approval Date

2015-05-08

Regulatory Status

RX

2009
09 Dec
RX Application: 90485

Drug Name

TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;37.5MG

Approval Date

2009-12-09

90485 / 1

Active Ingredient

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Application Number

90485

Product Number

1

Dosage Form

-

Strength

325MG;37.5MG

Approval Date

2009-12-09

Regulatory Status

RX

2016
13 Apr
RX Application: 205034

Drug Name

VORICONAZOLE

Product Number

1

Dosage Form

-

Strength

200MG/5ML

Approval Date

2016-04-13

205034 / 1

Active Ingredient

VORICONAZOLE

Application Number

205034

Product Number

1

Dosage Form

-

Strength

200MG/5ML

Approval Date

2016-04-13

Regulatory Status

RX

2013
04 Mar
RX Application: 202202

Drug Name

WARFARIN SODIUM

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2013-03-04

202202 / 1

Active Ingredient

WARFARIN SODIUM

Application Number

202202

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2013-03-04

Regulatory Status

RX

2013
04 Mar
RX Application: 202202

Drug Name

WARFARIN SODIUM

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2013-03-04

202202 / 2

Active Ingredient

WARFARIN SODIUM

Application Number

202202

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2013-03-04

Regulatory Status

RX

2013
04 Mar
RX Application: 202202

Drug Name

WARFARIN SODIUM

Product Number

3

Dosage Form

-

Strength

2.5MG

Approval Date

2013-03-04

202202 / 3

Active Ingredient

WARFARIN SODIUM

Application Number

202202

Product Number

3

Dosage Form

-

Strength

2.5MG

Approval Date

2013-03-04

Regulatory Status

RX

2013
04 Mar
RX Application: 202202

Drug Name

WARFARIN SODIUM

Product Number

4

Dosage Form

-

Strength

3MG

Approval Date

2013-03-04

202202 / 4

Active Ingredient

WARFARIN SODIUM

Application Number

202202

Product Number

4

Dosage Form

-

Strength

3MG

Approval Date

2013-03-04

Regulatory Status

RX

2013
04 Mar
RX Application: 202202

Drug Name

WARFARIN SODIUM

Product Number

5

Dosage Form

-

Strength

4MG

Approval Date

2013-03-04

202202 / 5

Active Ingredient

WARFARIN SODIUM

Application Number

202202

Product Number

5

Dosage Form

-

Strength

4MG

Approval Date

2013-03-04

Regulatory Status

RX

2013
04 Mar
RX Application: 202202

Drug Name

WARFARIN SODIUM

Product Number

6

Dosage Form

-

Strength

5MG

Approval Date

2013-03-04

202202 / 6

Active Ingredient

WARFARIN SODIUM

Application Number

202202

Product Number

6

Dosage Form

-

Strength

5MG

Approval Date

2013-03-04

Regulatory Status

RX

2013
04 Mar
RX Application: 202202

Drug Name

WARFARIN SODIUM

Product Number

7

Dosage Form

-

Strength

6MG

Approval Date

2013-03-04

202202 / 7

Active Ingredient

WARFARIN SODIUM

Application Number

202202

Product Number

7

Dosage Form

-

Strength

6MG

Approval Date

2013-03-04

Regulatory Status

RX

2013
04 Mar
RX Application: 202202

Drug Name

WARFARIN SODIUM

Product Number

8

Dosage Form

-

Strength

7.5MG

Approval Date

2013-03-04

202202 / 8

Active Ingredient

WARFARIN SODIUM

Application Number

202202

Product Number

8

Dosage Form

-

Strength

7.5MG

Approval Date

2013-03-04

Regulatory Status

RX

2013
04 Mar
RX Application: 202202

Drug Name

WARFARIN SODIUM

Product Number

9

Dosage Form

-

Strength

10MG

Approval Date

2013-03-04

202202 / 9

Active Ingredient

WARFARIN SODIUM

Application Number

202202

Product Number

9

Dosage Form

-

Strength

10MG

Approval Date

2013-03-04

Regulatory Status

RX

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Drug Status Breakdown
96 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

ACYCLOVIR

Application Number

204605

Product Number

1

Active Ingredient

ACYCLOVIR

Dosage Form

-

Strength

5%

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

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