Aurolife Pharma LLC
FDA Approved Drugs

Aurolife Pharma LLC

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 Discontinued Unclassified OTC
  • Total Records 74
  • Latest Approval Date Feb 03, 2023
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
74
View
Unclassified
2
View
Discontinued
26
View
OTC
1
View
RX
45
View
Company Overview

Company

Aurolife Pharma LLC

Country

U.S.A

Website

Visit Website

Email

achopra@aurobindousa.com

Social Profiles

Company Snapshot

Aurolife Pharma LLC

2400 US HWY 130 N Dayton, NJ 08810

U.S.A

www.aurolifepharma.com/ achopra@aurobindousa.com View on Map
FDA Approved Drug Records ( 74 records )
2013
15 Apr
RX Application: 202800

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;15MG

Approval Date

2013-04-15

202800 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

202800

Product Number

1

Dosage Form

-

Strength

300MG;15MG

Approval Date

2013-04-15

Regulatory Status

RX

2013
15 Apr
RX Application: 202800

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

2

Dosage Form

-

Strength

300MG;30MG

Approval Date

2013-04-15

202800 / 2

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

202800

Product Number

2

Dosage Form

-

Strength

300MG;30MG

Approval Date

2013-04-15

Regulatory Status

RX

2013
15 Apr
RX Application: 202800

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

3

Dosage Form

-

Strength

300MG;60MG

Approval Date

2013-04-15

202800 / 3

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

202800

Product Number

3

Dosage Form

-

Strength

300MG;60MG

Approval Date

2013-04-15

Regulatory Status

RX

2019
17 Apr
RX Application: 211639

Drug Name

AMPHETAMINE SULFATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-04-17

211639 / 1

Active Ingredient

AMPHETAMINE SULFATE

Application Number

211639

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2019-04-17

Regulatory Status

RX

2019
17 Apr
RX Application: 211639

Drug Name

AMPHETAMINE SULFATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-04-17

211639 / 2

Active Ingredient

AMPHETAMINE SULFATE

Application Number

211639

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2019-04-17

Regulatory Status

RX

2018
26 Sep
RX Application: 204733

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

2018-09-26

204733 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Application Number

204733

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

2018-09-26

Regulatory Status

RX

1988
12 Aug
Discontinued Application: 70797

Drug Name

CHLORPHENIRAMINE MALEATE

Product Number

1

Dosage Form

-

Strength

12MG

Approval Date

1988-08-12

70797 / 1

Active Ingredient

CHLORPHENIRAMINE MALEATE

Application Number

70797

Product Number

1

Dosage Form

-

Strength

12MG

Approval Date

1988-08-12

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 80961

Drug Name

CHLORPHENIRAMINE MALEATE

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

80961 / 1

Active Ingredient

CHLORPHENIRAMINE MALEATE

Application Number

80961

Product Number

1

Dosage Form

-

Strength

4MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

-
Unclassified Application: 72219

Drug Name

CLORAZEPATE DIPOTASSIUM

Product Number

1

Dosage Form

-

Strength

3.75MG

Approval Date

-

72219 / 1

Active Ingredient

CLORAZEPATE DIPOTASSIUM

Application Number

72219

Product Number

1

Dosage Form

-

Strength

3.75MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 72220

Drug Name

CLORAZEPATE DIPOTASSIUM

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

-

72220 / 1

Active Ingredient

CLORAZEPATE DIPOTASSIUM

Application Number

72220

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

-

Regulatory Status

Unclassified

1990
11 May
Discontinued Application: 72514

Drug Name

CLORAZEPATE DIPOTASSIUM

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1990-05-11

72514 / 1

Active Ingredient

CLORAZEPATE DIPOTASSIUM

Application Number

72514

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1990-05-11

Regulatory Status

Discontinued

1990
11 May
Discontinued Application: 72514

Drug Name

CLORAZEPATE DIPOTASSIUM

Product Number

2

Dosage Form

-

Strength

3.75MG

Approval Date

1990-05-11

72514 / 2

Active Ingredient

CLORAZEPATE DIPOTASSIUM

Application Number

72514

Product Number

2

Dosage Form

-

Strength

3.75MG

Approval Date

1990-05-11

Regulatory Status

Discontinued

1990
11 May
Discontinued Application: 72514

Drug Name

CLORAZEPATE DIPOTASSIUM

Product Number

3

Dosage Form

-

Strength

7.5MG

Approval Date

1990-05-11

72514 / 3

Active Ingredient

CLORAZEPATE DIPOTASSIUM

Application Number

72514

Product Number

3

Dosage Form

-

Strength

7.5MG

Approval Date

1990-05-11

Regulatory Status

Discontinued

2013
28 Aug
Discontinued Application: 202580

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2013-08-28

202580 / 1

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

202580

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2013-08-28

Regulatory Status

Discontinued

2015
25 Aug
Discontinued Application: 202580

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2015-08-25

202580 / 2

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

202580

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2015-08-25

Regulatory Status

Discontinued

2015
25 Aug
Discontinued Application: 202580

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2015-08-25

202580 / 3

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

202580

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2015-08-25

Regulatory Status

Discontinued

2015
25 Aug
Discontinued Application: 202580

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2015-08-25

202580 / 4

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

202580

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2015-08-25

Regulatory Status

Discontinued

2015
21 Dec
Discontinued Application: 202580

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2015-12-21

202580 / 5

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

202580

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2015-12-21

Regulatory Status

Discontinued

2021
04 May
Discontinued Application: 202580

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

25MG

Approval Date

2021-05-04

202580 / 6

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

202580

Product Number

6

Dosage Form

-

Strength

25MG

Approval Date

2021-05-04

Regulatory Status

Discontinued

2021
04 May
Discontinued Application: 202580

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

7

Dosage Form

-

Strength

35MG

Approval Date

2021-05-04

202580 / 7

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

202580

Product Number

7

Dosage Form

-

Strength

35MG

Approval Date

2021-05-04

Regulatory Status

Discontinued

2015
25 Aug
Discontinued Application: 202580

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

8

Dosage Form

-

Strength

40MG

Approval Date

2015-08-25

202580 / 8

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

202580

Product Number

8

Dosage Form

-

Strength

40MG

Approval Date

2015-08-25

Regulatory Status

Discontinued

2013
27 Nov
RX Application: 202424

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2013-11-27

202424 / 1

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

202424

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2013-11-27

Regulatory Status

RX

2013
27 Nov
RX Application: 202424

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

2

Dosage Form

-

Strength

1.875MG;1.875MG;1.875MG;1.875MG

Approval Date

2013-11-27

202424 / 2

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

202424

Product Number

2

Dosage Form

-

Strength

1.875MG;1.875MG;1.875MG;1.875MG

Approval Date

2013-11-27

Regulatory Status

RX

2013
27 Nov
RX Application: 202424

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

3

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2013-11-27

202424 / 3

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

202424

Product Number

3

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2013-11-27

Regulatory Status

RX

2013
27 Nov
RX Application: 202424

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

4

Dosage Form

-

Strength

3.125MG;3.125MG;3.125MG;3.125MG

Approval Date

2013-11-27

202424 / 4

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

202424

Product Number

4

Dosage Form

-

Strength

3.125MG;3.125MG;3.125MG;3.125MG

Approval Date

2013-11-27

Regulatory Status

RX

2013
27 Nov
RX Application: 202424

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

5

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG

Approval Date

2013-11-27

202424 / 5

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

202424

Product Number

5

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG

Approval Date

2013-11-27

Regulatory Status

RX

2013
27 Nov
RX Application: 202424

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

6

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2013-11-27

202424 / 6

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

202424

Product Number

6

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2013-11-27

Regulatory Status

RX

2013
27 Nov
RX Application: 202424

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

7

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2013-11-27

202424 / 7

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

202424

Product Number

7

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2013-11-27

Regulatory Status

RX

2020
24 Jun
Discontinued Application: 211876

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2020-06-24

211876 / 1

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

211876

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2020-06-24

Regulatory Status

Discontinued

2020
24 Jun
Discontinued Application: 211876

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

2

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2020-06-24

211876 / 2

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

211876

Product Number

2

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2020-06-24

Regulatory Status

Discontinued

2020
24 Jun
Discontinued Application: 211876

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

3

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG

Approval Date

2020-06-24

211876 / 3

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

211876

Product Number

3

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG

Approval Date

2020-06-24

Regulatory Status

Discontinued

2020
24 Jun
Discontinued Application: 211876

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

4

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2020-06-24

211876 / 4

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

211876

Product Number

4

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2020-06-24

Regulatory Status

Discontinued

2020
24 Jun
Discontinued Application: 211876

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

5

Dosage Form

-

Strength

6.25MG;6.25MG;6.25MG;6.25MG

Approval Date

2020-06-24

211876 / 5

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

211876

Product Number

5

Dosage Form

-

Strength

6.25MG;6.25MG;6.25MG;6.25MG

Approval Date

2020-06-24

Regulatory Status

Discontinued

2020
24 Jun
Discontinued Application: 211876

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

6

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2020-06-24

211876 / 6

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

211876

Product Number

6

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2020-06-24

Regulatory Status

Discontinued

2013
31 Jul
RX Application: 202893

Drug Name

DEXTROAMPHETAMINE SULFATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2013-07-31

202893 / 1

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

202893

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2013-07-31

Regulatory Status

RX

2013
31 Jul
RX Application: 202893

Drug Name

DEXTROAMPHETAMINE SULFATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2013-07-31

202893 / 2

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

202893

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2013-07-31

Regulatory Status

RX

2019
06 May
OTC Application: 204306

Drug Name

DICLOFENAC SODIUM

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2019-05-06

204306 / 1

Active Ingredient

DICLOFENAC SODIUM

Application Number

204306

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2019-05-06

Regulatory Status

OTC

2023
03 Feb
RX Application: 213040

Drug Name

DICLOFENAC SODIUM

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2023-02-03

213040 / 1

Active Ingredient

DICLOFENAC SODIUM

Application Number

213040

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2023-02-03

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 83899

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

83899 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

83899

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 85219

Drug Name

HYDROCHLOROTHIAZIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

85219 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE

Application Number

85219

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

2012
11 Apr
RX Application: 201013

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

2012-04-11

201013 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

201013

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

2012-04-11

Regulatory Status

RX

2012
11 Apr
RX Application: 201013

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2012-04-11

201013 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

201013

Product Number

2

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2012-04-11

Regulatory Status

RX

2012
11 Apr
RX Application: 201013

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

325MG;10MG

Approval Date

2012-04-11

201013 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

201013

Product Number

3

Dosage Form

-

Strength

325MG;10MG

Approval Date

2012-04-11

Regulatory Status

RX

2018
13 Sep
RX Application: 207709

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

300MG;5MG

Approval Date

2018-09-13

207709 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

207709

Product Number

1

Dosage Form

-

Strength

300MG;5MG

Approval Date

2018-09-13

Regulatory Status

RX

2018
13 Sep
RX Application: 207709

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

300MG;7.5MG

Approval Date

2018-09-13

207709 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

207709

Product Number

2

Dosage Form

-

Strength

300MG;7.5MG

Approval Date

2018-09-13

Regulatory Status

RX

2018
13 Sep
RX Application: 207709

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

300MG;10MG

Approval Date

2018-09-13

207709 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

207709

Product Number

3

Dosage Form

-

Strength

300MG;10MG

Approval Date

2018-09-13

Regulatory Status

RX

2016
02 Jun
RX Application: 204575

Drug Name

HYDROCODONE BITARTRATE AND IBUPROFEN

Product Number

1

Dosage Form

-

Strength

7.5MG;200MG

Approval Date

2016-06-02

204575 / 1

Active Ingredient

HYDROCODONE BITARTRATE; IBUPROFEN

Application Number

204575

Product Number

1

Dosage Form

-

Strength

7.5MG;200MG

Approval Date

2016-06-02

Regulatory Status

RX

2016
13 May
RX Application: 205814

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2016-05-13

205814 / 1

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

205814

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2016-05-13

Regulatory Status

RX

2016
13 May
RX Application: 205814

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2016-05-13

205814 / 2

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

205814

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2016-05-13

Regulatory Status

RX

2016
13 May
RX Application: 205814

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

8MG

Approval Date

2016-05-13

205814 / 3

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

205814

Product Number

3

Dosage Form

-

Strength

8MG

Approval Date

2016-05-13

Regulatory Status

RX

2015
31 Aug
RX Application: 203502

Drug Name

METHADONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-08-31

203502 / 1

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

203502

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2015-08-31

Regulatory Status

RX

2015
31 Aug
RX Application: 203502

Drug Name

METHADONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2015-08-31

203502 / 2

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

203502

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2015-08-31

Regulatory Status

RX

2016
21 Oct
RX Application: 206726

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

18MG

Approval Date

2016-10-21

206726 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

206726

Product Number

1

Dosage Form

-

Strength

18MG

Approval Date

2016-10-21

Regulatory Status

RX

2016
21 Oct
RX Application: 206726

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

27MG

Approval Date

2016-10-21

206726 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

206726

Product Number

2

Dosage Form

-

Strength

27MG

Approval Date

2016-10-21

Regulatory Status

RX

2016
21 Oct
RX Application: 206726

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

36MG

Approval Date

2016-10-21

206726 / 3

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

206726

Product Number

3

Dosage Form

-

Strength

36MG

Approval Date

2016-10-21

Regulatory Status

RX

2016
21 Oct
RX Application: 206726

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

54MG

Approval Date

2016-10-21

206726 / 4

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

206726

Product Number

4

Dosage Form

-

Strength

54MG

Approval Date

2016-10-21

Regulatory Status

RX

2018
25 Oct
Discontinued Application: 209276

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2018-10-25

209276 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

209276

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2018-10-25

Regulatory Status

Discontinued

2018
25 Oct
Discontinued Application: 209276

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2018-10-25

209276 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

209276

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2018-10-25

Regulatory Status

Discontinued

2018
25 Oct
Discontinued Application: 209276

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2018-10-25

209276 / 3

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

209276

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2018-10-25

Regulatory Status

Discontinued

2016
19 Aug
RX Application: 204922

Drug Name

OMEPRAZOLE AND SODIUM BICARBONATE

Product Number

1

Dosage Form

-

Strength

20MG;1.1GM

Approval Date

2016-08-19

204922 / 1

Active Ingredient

OMEPRAZOLE; SODIUM BICARBONATE

Application Number

204922

Product Number

1

Dosage Form

-

Strength

20MG;1.1GM

Approval Date

2016-08-19

Regulatory Status

RX

2016
19 Aug
RX Application: 204922

Drug Name

OMEPRAZOLE AND SODIUM BICARBONATE

Product Number

2

Dosage Form

-

Strength

40MG;1.1GM

Approval Date

2016-08-19

204922 / 2

Active Ingredient

OMEPRAZOLE; SODIUM BICARBONATE

Application Number

204922

Product Number

2

Dosage Form

-

Strength

40MG;1.1GM

Approval Date

2016-08-19

Regulatory Status

RX

2013
15 Jul
RX Application: 201972

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;2.5MG

Approval Date

2013-07-15

201972 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

201972

Product Number

1

Dosage Form

-

Strength

325MG;2.5MG

Approval Date

2013-07-15

Regulatory Status

RX

2013
15 Jul
RX Application: 201972

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;5MG

Approval Date

2013-07-15

201972 / 2

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

201972

Product Number

2

Dosage Form

-

Strength

325MG;5MG

Approval Date

2013-07-15

Regulatory Status

RX

2013
15 Jul
RX Application: 201972

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2013-07-15

201972 / 3

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

201972

Product Number

3

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2013-07-15

Regulatory Status

RX

2013
15 Jul
RX Application: 201972

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

4

Dosage Form

-

Strength

325MG;10MG

Approval Date

2013-07-15

201972 / 4

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

201972

Product Number

4

Dosage Form

-

Strength

325MG;10MG

Approval Date

2013-07-15

Regulatory Status

RX

2012
19 Nov
RX Application: 202160

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2012-11-19

202160 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

202160

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2012-11-19

Regulatory Status

RX

2012
19 Nov
RX Application: 202160

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2012-11-19

202160 / 2

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

202160

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2012-11-19

Regulatory Status

RX

2012
19 Nov
RX Application: 202160

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2012-11-19

202160 / 3

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

202160

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2012-11-19

Regulatory Status

RX

2020
27 Jan
Discontinued Application: 212429

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2020-01-27

212429 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

212429

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2020-01-27

Regulatory Status

Discontinued

2020
27 Jan
Discontinued Application: 212429

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG/5ML

Approval Date

2020-01-27

212429 / 2

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

212429

Product Number

2

Dosage Form

-

Strength

100MG/5ML

Approval Date

2020-01-27

Regulatory Status

Discontinued

2016
26 Apr
RX Application: 204459

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2016-04-26

204459 / 1

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

204459

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2016-04-26

Regulatory Status

RX

2016
26 Apr
RX Application: 204459

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2016-04-26

204459 / 2

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

204459

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2016-04-26

Regulatory Status

RX

2016
09 Nov
RX Application: 204318

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2016-11-09

204318 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

204318

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2016-11-09

Regulatory Status

RX

2016
09 Nov
RX Application: 204318

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2016-11-09

204318 / 2

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

204318

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2016-11-09

Regulatory Status

RX

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  • FDA Approved Drugs Database
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Drug Status Breakdown
74 total
  • RX
  • Discontinued
  • Unclassified
  • OTC
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

ACETAMINOPHEN AND CODEINE PHOSPHATE

Application Number

202800

Product Number

1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Dosage Form

-

Strength

300MG;15MG

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

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Searchable pharmaceutical data

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Organized FDA drug records

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