Mallinckrodt Pharmaceuticals RX
FDA Approved Drugs

Mallinckrodt 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 119
  • Latest Approval Date Jun 03, 2026
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
244
View
Unclassified
4
View
Discontinued
121
View
RX
119
View
Company Overview

Company

Mallinckrodt Pharmaceuticals RX

Country

Ireland

Website

Visit Website

Email

simon.plevin@mnk.com

Social Profiles

LinkedIn X / Twitter
Company Snapshot

Mallinckrodt Pharmaceuticals RX

College Business & Technology Park Cruiserath, Blanchardstown Dublin 15

Ireland

www.mallinckrodt.com/ simon.plevin@mnk.com View on Map
FDA Approved Drug Records ( 119 records )
2001
31 May
RX Application: 40419

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;15MG

Approval Date

2001-05-31

40419 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

40419

Product Number

1

Dosage Form

-

Strength

300MG;15MG

Approval Date

2001-05-31

Regulatory Status

RX

2001
31 May
RX Application: 40419

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

2

Dosage Form

-

Strength

300MG;30MG

Approval Date

2001-05-31

40419 / 2

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

40419

Product Number

2

Dosage Form

-

Strength

300MG;30MG

Approval Date

2001-05-31

Regulatory Status

RX

2001
31 May
RX Application: 40419

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

3

Dosage Form

-

Strength

300MG;60MG

Approval Date

2001-05-31

40419 / 3

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

40419

Product Number

3

Dosage Form

-

Strength

300MG;60MG

Approval Date

2001-05-31

Regulatory Status

RX

2021
22 Jan
RX Application: 213583

Drug Name

AMPHETAMINE SULFATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2021-01-22

213583 / 1

Active Ingredient

AMPHETAMINE SULFATE

Application Number

213583

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2021-01-22

Regulatory Status

RX

2021
22 Jan
RX Application: 213583

Drug Name

AMPHETAMINE SULFATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2021-01-22

213583 / 2

Active Ingredient

AMPHETAMINE SULFATE

Application Number

213583

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2021-01-22

Regulatory Status

RX

1989
29 Dec
RX Application: 19906

Drug Name

ANAFRANIL

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1989-12-29

19906 / 1

Active Ingredient

CLOMIPRAMINE HYDROCHLORIDE

Application Number

19906

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1989-12-29

Regulatory Status

RX

1989
29 Dec
RX Application: 19906

Drug Name

ANAFRANIL

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1989-12-29

19906 / 2

Active Ingredient

CLOMIPRAMINE HYDROCHLORIDE

Application Number

19906

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1989-12-29

Regulatory Status

RX

1989
29 Dec
RX Application: 19906

Drug Name

ANAFRANIL

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

1989-12-29

19906 / 3

Active Ingredient

CLOMIPRAMINE HYDROCHLORIDE

Application Number

19906

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

1989-12-29

Regulatory Status

RX

2000
20 Oct
RX Application: 40409

Drug Name

ANEXSIA 5/325

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

2000-10-20

40409 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40409

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

2000-10-20

Regulatory Status

RX

2000
08 Sep
RX Application: 40405

Drug Name

ANEXSIA 7.5/325

Product Number

1

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2000-09-08

40405 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40405

Product Number

1

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2000-09-08

Regulatory Status

RX

2025
10 Dec
RX Application: 218473

Drug Name

BUPRENORPHINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2025-12-10

218473 / 1

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE

Application Number

218473

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2025-12-10

Regulatory Status

RX

2025
10 Dec
RX Application: 218473

Drug Name

BUPRENORPHINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2025-12-10

218473 / 2

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE

Application Number

218473

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2025-12-10

Regulatory Status

RX

2017
13 Dec
RX Application: 207000

Drug Name

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE;EQ 0.5MG BASE

Approval Date

2017-12-13

207000 / 1

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Application Number

207000

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE;EQ 0.5MG BASE

Approval Date

2017-12-13

Regulatory Status

RX

2017
13 Dec
RX Application: 207000

Drug Name

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE;EQ 2MG BASE

Approval Date

2017-12-13

207000 / 2

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Application Number

207000

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE;EQ 2MG BASE

Approval Date

2017-12-13

Regulatory Status

RX

2003
07 Oct
RX Application: 40440

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

2003-10-07

40440 / 1

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

40440

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2003-10-07

Regulatory Status

RX

2003
07 Oct
RX Application: 40440

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

2003-10-07

40440 / 2

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

40440

Product Number

2

Dosage Form

-

Strength

1.875MG;1.875MG;1.875MG;1.875MG

Approval Date

2003-10-07

Regulatory Status

RX

2003
07 Oct
RX Application: 40440

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

2003-10-07

40440 / 3

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

40440

Product Number

3

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2003-10-07

Regulatory Status

RX

2003
07 Oct
RX Application: 40440

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

2003-10-07

40440 / 4

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

40440

Product Number

4

Dosage Form

-

Strength

3.125MG;3.125MG;3.125MG;3.125MG

Approval Date

2003-10-07

Regulatory Status

RX

2003
07 Oct
RX Application: 40440

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

2003-10-07

40440 / 5

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

40440

Product Number

5

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG

Approval Date

2003-10-07

Regulatory Status

RX

2003
07 Oct
RX Application: 40440

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

6

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2003-10-07

40440 / 6

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

40440

Product Number

6

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2003-10-07

Regulatory Status

RX

2003
07 Oct
RX Application: 40440

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

2003-10-07

40440 / 7

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

40440

Product Number

7

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2003-10-07

Regulatory Status

RX

2023
31 Aug
RX Application: 211546

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

1

Dosage Form

-

Strength

3.125MG;3.125MG;3.125MG;3.125MG

Approval Date

2023-08-31

211546 / 1

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

211546

Product Number

1

Dosage Form

-

Strength

3.125MG;3.125MG;3.125MG;3.125MG

Approval Date

2023-08-31

Regulatory Status

RX

2023
31 Aug
RX Application: 211546

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

2

Dosage Form

-

Strength

6.25MG;6.25MG;6.25MG;6.25MG

Approval Date

2023-08-31

211546 / 2

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

211546

Product Number

2

Dosage Form

-

Strength

6.25MG;6.25MG;6.25MG;6.25MG

Approval Date

2023-08-31

Regulatory Status

RX

2023
31 Aug
RX Application: 211546

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

3

Dosage Form

-

Strength

9.375MG;9.375MG;9.375MG;9.375MG

Approval Date

2023-08-31

211546 / 3

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

211546

Product Number

3

Dosage Form

-

Strength

9.375MG;9.375MG;9.375MG;9.375MG

Approval Date

2023-08-31

Regulatory Status

RX

2023
31 Aug
RX Application: 211546

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

4

Dosage Form

-

Strength

12.5MG;12.5MG;12.5MG;12.5MG

Approval Date

2023-08-31

211546 / 4

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

211546

Product Number

4

Dosage Form

-

Strength

12.5MG;12.5MG;12.5MG;12.5MG

Approval Date

2023-08-31

Regulatory Status

RX

2019
22 Apr
RX Application: 211547

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

2019-04-22

211547 / 1

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

211547

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2019-04-22

Regulatory Status

RX

2019
22 Apr
RX Application: 211547

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

2019-04-22

211547 / 2

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

211547

Product Number

2

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2019-04-22

Regulatory Status

RX

2019
22 Apr
RX Application: 211547

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

2019-04-22

211547 / 3

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

211547

Product Number

3

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG

Approval Date

2019-04-22

Regulatory Status

RX

2019
22 Apr
RX Application: 211547

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

4

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2019-04-22

211547 / 4

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

211547

Product Number

4

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2019-04-22

Regulatory Status

RX

2019
22 Apr
RX Application: 211547

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

2019-04-22

211547 / 5

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

211547

Product Number

5

Dosage Form

-

Strength

6.25MG;6.25MG;6.25MG;6.25MG

Approval Date

2019-04-22

Regulatory Status

RX

2019
22 Apr
RX Application: 211547

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

2019-04-22

211547 / 6

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

211547

Product Number

6

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2019-04-22

Regulatory Status

RX

2002
29 Jan
RX Application: 40436

Drug Name

DEXTROAMPHETAMINE SULFATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2002-01-29

40436 / 1

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

40436

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2002-01-29

Regulatory Status

RX

2002
29 Jan
RX Application: 40436

Drug Name

DEXTROAMPHETAMINE SULFATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2002-01-29

40436 / 2

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

40436

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2002-01-29

Regulatory Status

RX

2003
06 May
RX Application: 76353

Drug Name

DEXTROAMPHETAMINE SULFATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2003-05-06

76353 / 1

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

76353

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2003-05-06

Regulatory Status

RX

2003
06 May
RX Application: 76353

Drug Name

DEXTROAMPHETAMINE SULFATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2003-05-06

76353 / 2

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

76353

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2003-05-06

Regulatory Status

RX

2003
06 May
RX Application: 76353

Drug Name

DEXTROAMPHETAMINE SULFATE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2003-05-06

76353 / 3

Active Ingredient

DEXTROAMPHETAMINE SULFATE

Application Number

76353

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2003-05-06

Regulatory Status

RX

2020
06 Oct
RX Application: 213335

Drug Name

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

Product Number

1

Dosage Form

-

Strength

0.025MG;2.5MG

Approval Date

2020-10-06

213335 / 1

Active Ingredient

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

Application Number

213335

Product Number

1

Dosage Form

-

Strength

0.025MG;2.5MG

Approval Date

2020-10-06

Regulatory Status

RX

2011
09 Feb
RX Application: 77154

Drug Name

FENTANYL-100

Product Number

4

Dosage Form

-

Strength

100MCG/HR

Approval Date

2011-02-09

77154 / 4

Active Ingredient

FENTANYL

Application Number

77154

Product Number

4

Dosage Form

-

Strength

100MCG/HR

Approval Date

2011-02-09

Regulatory Status

RX

2015
11 Jun
RX Application: 77154

Drug Name

FENTANYL-12

Product Number

5

Dosage Form

-

Strength

12.5MCG/HR

Approval Date

2015-06-11

77154 / 5

Active Ingredient

FENTANYL

Application Number

77154

Product Number

5

Dosage Form

-

Strength

12.5MCG/HR

Approval Date

2015-06-11

Regulatory Status

RX

2011
09 Feb
RX Application: 77154

Drug Name

FENTANYL-25

Product Number

1

Dosage Form

-

Strength

25MCG/HR

Approval Date

2011-02-09

77154 / 1

Active Ingredient

FENTANYL

Application Number

77154

Product Number

1

Dosage Form

-

Strength

25MCG/HR

Approval Date

2011-02-09

Regulatory Status

RX

2020
14 Jan
RX Application: 77154

Drug Name

FENTANYL-37

Product Number

6

Dosage Form

-

Strength

37.5MCG/HR

Approval Date

2020-01-14

77154 / 6

Active Ingredient

FENTANYL

Application Number

77154

Product Number

6

Dosage Form

-

Strength

37.5MCG/HR

Approval Date

2020-01-14

Regulatory Status

RX

2011
09 Feb
RX Application: 77154

Drug Name

FENTANYL-50

Product Number

2

Dosage Form

-

Strength

50MCG/HR

Approval Date

2011-02-09

77154 / 2

Active Ingredient

FENTANYL

Application Number

77154

Product Number

2

Dosage Form

-

Strength

50MCG/HR

Approval Date

2011-02-09

Regulatory Status

RX

2020
14 Jan
RX Application: 77154

Drug Name

FENTANYL-62

Product Number

7

Dosage Form

-

Strength

62.5MCG/HR

Approval Date

2020-01-14

77154 / 7

Active Ingredient

FENTANYL

Application Number

77154

Product Number

7

Dosage Form

-

Strength

62.5MCG/HR

Approval Date

2020-01-14

Regulatory Status

RX

2011
09 Feb
RX Application: 77154

Drug Name

FENTANYL-75

Product Number

3

Dosage Form

-

Strength

75MCG/HR

Approval Date

2011-02-09

77154 / 3

Active Ingredient

FENTANYL

Application Number

77154

Product Number

3

Dosage Form

-

Strength

75MCG/HR

Approval Date

2011-02-09

Regulatory Status

RX

2000
26 Jul
RX Application: 40400

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;10MG

Approval Date

2000-07-26

40400 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40400

Product Number

1

Dosage Form

-

Strength

325MG;10MG

Approval Date

2000-07-26

Regulatory Status

RX

2017
31 Mar
RX Application: 206718

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

300MG;5MG

Approval Date

2017-03-31

206718 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

206718

Product Number

1

Dosage Form

-

Strength

300MG;5MG

Approval Date

2017-03-31

Regulatory Status

RX

2017
31 Mar
RX Application: 206718

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

300MG;7.5MG

Approval Date

2017-03-31

206718 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

206718

Product Number

2

Dosage Form

-

Strength

300MG;7.5MG

Approval Date

2017-03-31

Regulatory Status

RX

2017
31 Mar
RX Application: 206718

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

300MG;10MG

Approval Date

2017-03-31

206718 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

206718

Product Number

3

Dosage Form

-

Strength

300MG;10MG

Approval Date

2017-03-31

Regulatory Status

RX

2004
23 Dec
RX Application: 76855

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

8MG

Approval Date

2004-12-23

76855 / 1

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

76855

Product Number

1

Dosage Form

-

Strength

8MG

Approval Date

2004-12-23

Regulatory Status

RX

2007
19 Sep
RX Application: 76855

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2007-09-19

76855 / 2

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

76855

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2007-09-19

Regulatory Status

RX

2007
19 Sep
RX Application: 76855

Drug Name

HYDROMORPHONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

4MG

Approval Date

2007-09-19

76855 / 3

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

76855

Product Number

3

Dosage Form

-

Strength

4MG

Approval Date

2007-09-19

Regulatory Status

RX

2019
13 Dec
RX Application: 212024

Drug Name

LEVORPHANOL TARTRATE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2019-12-13

212024 / 1

Active Ingredient

LEVORPHANOL TARTRATE

Application Number

212024

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2019-12-13

Regulatory Status

RX

2023
25 Aug
RX Application: 211840

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2023-08-25

211840 / 1

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

211840

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 211840

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2023-08-25

211840 / 2

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

211840

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 211840

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2023-08-25

211840 / 3

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

211840

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 211840

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2023-08-25

211840 / 4

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

211840

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 211840

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2023-08-25

211840 / 5

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

211840

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 211840

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2023-08-25

211840 / 6

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

211840

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 211840

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

7

Dosage Form

-

Strength

70MG

Approval Date

2023-08-25

211840 / 7

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

211840

Product Number

7

Dosage Form

-

Strength

70MG

Approval Date

2023-08-25

Regulatory Status

RX

2024
17 Dec
RX Application: 218850

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2024-12-17

218850 / 1

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

218850

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2024-12-17

Regulatory Status

RX

2024
17 Dec
RX Application: 218850

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2024-12-17

218850 / 2

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

218850

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2024-12-17

Regulatory Status

RX

2024
17 Dec
RX Application: 218850

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2024-12-17

218850 / 3

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

218850

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2024-12-17

Regulatory Status

RX

2024
17 Dec
RX Application: 218850

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2024-12-17

218850 / 4

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

218850

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2024-12-17

Regulatory Status

RX

2024
17 Dec
RX Application: 218850

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2024-12-17

218850 / 5

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

218850

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2024-12-17

Regulatory Status

RX

2024
17 Dec
RX Application: 218850

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2024-12-17

218850 / 6

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

218850

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2024-12-17

Regulatory Status

RX

2004
27 Apr
RX Application: 40517

Drug Name

METHADONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2004-04-27

40517 / 1

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

40517

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2004-04-27

Regulatory Status

RX

2004
27 Apr
RX Application: 40517

Drug Name

METHADONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2004-04-27

40517 / 2

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

40517

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2004-04-27

Regulatory Status

RX

2005
12 Jul
RX Application: 77142

Drug Name

METHADONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2005-07-12

77142 / 1

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

77142

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

2005-07-12

Regulatory Status

RX

2019
22 Aug
RX Application: 207368

Drug Name

METHADONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2019-08-22

207368 / 1

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

207368

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2019-08-22

Regulatory Status

RX

2019
02 Oct
RX Application: 207537

Drug Name

METHADONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2019-10-02

207537 / 1

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

207537

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2019-10-02

Regulatory Status

RX

2019
01 Oct
RX Application: 207537

Drug Name

METHADONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG/5ML

Approval Date

2019-10-01

207537 / 2

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

207537

Product Number

2

Dosage Form

-

Strength

10MG/5ML

Approval Date

2019-10-01

Regulatory Status

RX

1982
01 Jan
RX Application: 17116

Drug Name

METHADOSE

Product Number

2

Dosage Form

-

Strength

10MG/ML

Approval Date

1982-01-01

17116 / 2

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

17116

Product Number

2

Dosage Form

-

Strength

10MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

1993
29 Apr
RX Application: 74184

Drug Name

METHADOSE

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1993-04-29

74184 / 1

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

74184

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1993-04-29

Regulatory Status

RX

2002
19 Dec
RX Application: 21419

Drug Name

METHYLIN

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2002-12-19

21419 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

21419

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2002-12-19

Regulatory Status

RX

2002
19 Dec
RX Application: 21419

Drug Name

METHYLIN

Product Number

2

Dosage Form

-

Strength

10MG/5ML

Approval Date

2002-12-19

21419 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

21419

Product Number

2

Dosage Form

-

Strength

10MG/5ML

Approval Date

2002-12-19

Regulatory Status

RX

2000
09 May
RX Application: 75629

Drug Name

METHYLIN ER

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2000-05-09

75629 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

75629

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2000-05-09

Regulatory Status

RX

2000
09 May
RX Application: 75629

Drug Name

METHYLIN ER

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2000-05-09

75629 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

75629

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2000-05-09

Regulatory Status

RX

1998
27 Nov
RX Application: 40300

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1998-11-27

40300 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

40300

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1998-11-27

Regulatory Status

RX

1998
27 Nov
RX Application: 40300

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1998-11-27

40300 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

40300

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1998-11-27

Regulatory Status

RX

1998
27 Nov
RX Application: 40300

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

1998-11-27

40300 / 3

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

40300

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

1998-11-27

Regulatory Status

RX

2015
29 Sep
RX Application: 203583

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2015-09-29

203583 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

203583

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2015-09-29

Regulatory Status

RX

2015
29 Sep
RX Application: 203583

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2015-09-29

203583 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

203583

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2015-09-29

Regulatory Status

RX

2015
29 Sep
RX Application: 203583

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2015-09-29

203583 / 3

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

203583

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2015-09-29

Regulatory Status

RX

2015
29 Sep
RX Application: 203583

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2015-09-29

203583 / 4

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

203583

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2015-09-29

Regulatory Status

RX

2015
29 Sep
RX Application: 203583

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2015-09-29

203583 / 5

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

203583

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2015-09-29

Regulatory Status

RX

2015
29 Sep
RX Application: 203583

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2015-09-29

203583 / 6

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

203583

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2015-09-29

Regulatory Status

RX

2003
31 Jul
RX Application: 76412

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2003-07-31

76412 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

76412

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2003-07-31

Regulatory Status

RX

2003
31 Jul
RX Application: 76412

Drug Name

MORPHINE SULFATE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2003-07-31

76412 / 2

Active Ingredient

MORPHINE SULFATE

Application Number

76412

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2003-07-31

Regulatory Status

RX

2003
31 Jul
RX Application: 76412

Drug Name

MORPHINE SULFATE

Product Number

3

Dosage Form

-

Strength

60MG

Approval Date

2003-07-31

76412 / 3

Active Ingredient

MORPHINE SULFATE

Application Number

76412

Product Number

3

Dosage Form

-

Strength

60MG

Approval Date

2003-07-31

Regulatory Status

RX

2003
03 Jul
RX Application: 76438

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2003-07-03

76438 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

76438

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2003-07-03

Regulatory Status

RX

2003
03 Jul
RX Application: 76438

Drug Name

MORPHINE SULFATE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2003-07-03

76438 / 2

Active Ingredient

MORPHINE SULFATE

Application Number

76438

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2003-07-03

Regulatory Status

RX

2011
15 Jul
RX Application: 202348

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2011-07-15

202348 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

202348

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2011-07-15

Regulatory Status

RX

2023
21 Aug
RX Application: 215194

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2023-08-21

215194 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

215194

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2023-08-21

Regulatory Status

RX

2023
21 Aug
RX Application: 215194

Drug Name

MORPHINE SULFATE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2023-08-21

215194 / 2

Active Ingredient

MORPHINE SULFATE

Application Number

215194

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2023-08-21

Regulatory Status

RX

2002
22 Mar
RX Application: 76264

Drug Name

NALTREXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2002-03-22

76264 / 1

Active Ingredient

NALTREXONE HYDROCHLORIDE

Application Number

76264

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2002-03-22

Regulatory Status

RX

2002
22 Mar
RX Application: 76264

Drug Name

NALTREXONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2002-03-22

76264 / 2

Active Ingredient

NALTREXONE HYDROCHLORIDE

Application Number

76264

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2002-03-22

Regulatory Status

RX

2002
22 Mar
RX Application: 76264

Drug Name

NALTREXONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2002-03-22

76264 / 3

Active Ingredient

NALTREXONE HYDROCHLORIDE

Application Number

76264

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2002-03-22

Regulatory Status

RX

1983
07 Dec
RX Application: 87463

Drug Name

OXYCET

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

1983-12-07

87463 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

87463

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

1983-12-07

Regulatory Status

RX

2004
30 Jun
RX Application: 40545

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2004-06-30

40545 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

40545

Product Number

1

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2004-06-30

Regulatory Status

RX

2004
30 Jun
RX Application: 40545

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;10MG

Approval Date

2004-06-30

40545 / 2

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

40545

Product Number

2

Dosage Form

-

Strength

325MG;10MG

Approval Date

2004-06-30

Regulatory Status

RX

2004
30 Jun
RX Application: 76758

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2004-06-30

76758 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

76758

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2004-06-30

Regulatory Status

RX

2004
30 Jun
RX Application: 76758

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2004-06-30

76758 / 2

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

76758

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2004-06-30

Regulatory Status

RX

2007
19 Mar
RX Application: 76758

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2007-03-19

76758 / 3

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

76758

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2007-03-19

Regulatory Status

RX

2021
12 Oct
RX Application: 76758

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2021-10-12

76758 / 4

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

76758

Product Number

4

Dosage Form

-

Strength

10MG

Approval Date

2021-10-12

Regulatory Status

RX

2021
12 Oct
RX Application: 76758

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2021-10-12

76758 / 5

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

76758

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2021-10-12

Regulatory Status

RX

2018
30 Apr
RX Application: 210758

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2018-04-30

210758 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

210758

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2018-04-30

Regulatory Status

RX

2018
30 Apr
RX Application: 210758

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG/5ML

Approval Date

2018-04-30

210758 / 2

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

210758

Product Number

2

Dosage Form

-

Strength

100MG/5ML

Approval Date

2018-04-30

Regulatory Status

RX

2022
10 May
RX Application: 212226

Drug Name

POSACONAZOLE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2022-05-10

212226 / 1

Active Ingredient

POSACONAZOLE

Application Number

212226

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2022-05-10

Regulatory Status

RX

2025
24 Jun
RX Application: 219193

Drug Name

PRUCALOPRIDE SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2025-06-24

219193 / 1

Active Ingredient

PRUCALOPRIDE SUCCINATE

Application Number

219193

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2025-06-24

Regulatory Status

RX

2025
24 Jun
RX Application: 219193

Drug Name

PRUCALOPRIDE SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2025-06-24

219193 / 2

Active Ingredient

PRUCALOPRIDE SUCCINATE

Application Number

219193

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2025-06-24

Regulatory Status

RX

1982
01 Jan
RX Application: 18163

Drug Name

RESTORIL

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1982-01-01

18163 / 1

Active Ingredient

TEMAZEPAM

Application Number

18163

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 18163

Drug Name

RESTORIL

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

1982-01-01

18163 / 2

Active Ingredient

TEMAZEPAM

Application Number

18163

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

1982-01-01

Regulatory Status

RX

1991
25 Oct
RX Application: 18163

Drug Name

RESTORIL

Product Number

3

Dosage Form

-

Strength

7.5MG

Approval Date

1991-10-25

18163 / 3

Active Ingredient

TEMAZEPAM

Application Number

18163

Product Number

3

Dosage Form

-

Strength

7.5MG

Approval Date

1991-10-25

Regulatory Status

RX

2004
02 Nov
RX Application: 18163

Drug Name

RESTORIL

Product Number

4

Dosage Form

-

Strength

22.5MG

Approval Date

2004-11-02

18163 / 4

Active Ingredient

TEMAZEPAM

Application Number

18163

Product Number

4

Dosage Form

-

Strength

22.5MG

Approval Date

2004-11-02

Regulatory Status

RX

2000
31 Aug
RX Application: 21011

Drug Name

ROXICODONE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2000-08-31

21011 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

21011

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2000-08-31

Regulatory Status

RX

2000
31 Aug
RX Application: 21011

Drug Name

ROXICODONE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2000-08-31

21011 / 2

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

21011

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2000-08-31

Regulatory Status

RX

2009
15 May
RX Application: 21011

Drug Name

ROXICODONE

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2009-05-15

21011 / 3

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

21011

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2009-05-15

Regulatory Status

RX

2026
03 Jun
RX Application: 219395

Drug Name

TOFACITINIB CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2026-06-03

219395 / 1

Active Ingredient

TOFACITINIB CITRATE

Application Number

219395

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2026-06-03

Regulatory Status

RX

2026
03 Jun
RX Application: 219395

Drug Name

TOFACITINIB CITRATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2026-06-03

219395 / 2

Active Ingredient

TOFACITINIB CITRATE

Application Number

219395

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2026-06-03

Regulatory Status

RX

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Drug Status Breakdown
119 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

ACETAMINOPHEN AND CODEINE PHOSPHATE

Application Number

40419

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

Structured Database

Searchable pharmaceutical data

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Organized FDA drug records

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