Mallinckrodt Pharmaceuticals

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

Active Ingredient

CLOMIPRAMINE HYDROCHLORIDE

Application Number

19906

Product Number

3

Dosage Form

-

Strength

75MG

Approval Date

1989-12-29

Regulatory Status

RX

2002

31 Oct

Discontinued Application: 40468

Drug Name

ANEXSIA

Product Number

1

Dosage Form

-

Strength

750MG;10MG

Approval Date

2002-10-31

40468 / 1 View Details

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40468

Product Number

1

Dosage Form

-

Strength

750MG;10MG

Approval Date

2002-10-31

Regulatory Status

Discontinued

1987

23 Apr

Discontinued Application: 89160

Drug Name

ANEXSIA

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

1987-04-23

89160 / 1 View Details

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

89160

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

1987-04-23

Regulatory Status

Discontinued

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 View Details

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 View Details

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

1987

30 Sep

Discontinued Application: 89725

Drug Name

ANEXSIA 7.5/650

Product Number

1

Dosage Form

-

Strength

650MG;7.5MG

Approval Date

1987-09-30

89725 / 1 View Details

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

89725

Product Number

1

Dosage Form

-

Strength

650MG;7.5MG

Approval Date

1987-09-30

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 13319

Drug Name

ANGIO-CONRAY

Product Number

1

Dosage Form

-

Strength

80%

Approval Date

1982-01-01

13319 / 1 View Details

Active Ingredient

IOTHALAMATE SODIUM

Application Number

13319

Product Number

1

Dosage Form

-

Strength

80%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1985

07 Aug

Discontinued Application: 18509

Drug Name

BAROS

Product Number

1

Dosage Form

-

Strength

460MG/GM;420MG/GM

Approval Date

1985-08-07

18509 / 1 View Details

Active Ingredient

SODIUM BICARBONATE; TARTARIC ACID

Application Number

18509

Product Number

1

Dosage Form

-

Strength

460MG/GM;420MG/GM

Approval Date

1985-08-07

Regulatory Status

Discontinued

2007

25 Apr

Discontinued Application: 40773

Drug Name

BENZPHETAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2007-04-25

40773 / 1 View Details

Active Ingredient

BENZPHETAMINE HYDROCHLORIDE

Application Number

40773

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2007-04-25

Regulatory Status

Discontinued

1985

28 Jun

Discontinued Application: 88991

Drug Name

BUCET

Product Number

1

Dosage Form

-

Strength

650MG;50MG

Approval Date

1985-06-28

88991 / 1 View Details

Active Ingredient

ACETAMINOPHEN; BUTALBITAL

Application Number

88991

Product Number

1

Dosage Form

-

Strength

650MG;50MG

Approval Date

1985-06-28

Regulatory Status

Discontinued

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 View Details

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 View Details

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 View Details

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 View Details

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

1985

24 Jan

Discontinued Application: 87804

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

1985-01-24

87804 / 1 View Details

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Application Number

87804

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

1985-01-24

Regulatory Status

Discontinued

1985

18 Jul

Discontinued Application: 88743

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

1985-07-18

88743 / 1 View Details

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Application Number

88743

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

1985-07-18

Regulatory Status

Discontinued

1985

27 Mar

Discontinued Application: 88758

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

1985-03-27

88758 / 1 View Details

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Application Number

88758

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

1985-03-27

Regulatory Status

Discontinued

1985

27 Mar

Discontinued Application: 88765

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

1985-03-27

88765 / 1 View Details

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Application Number

88765

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

1985-03-27

Regulatory Status

Discontinued

1985

19 Apr

Discontinued Application: 89067

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

1985-04-19

89067 / 1 View Details

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Application Number

89067

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

1985-04-19

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 17129

Drug Name

CHOLEBRINE

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

1982-01-01

17129 / 1 View Details

Active Ingredient

IOCETAMIC ACID

Application Number

17129

Product Number

1

Dosage Form

-

Strength

750MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1985

25 Apr

Discontinued Application: 18793

Drug Name

COLD CAPSULE IV

Product Number

1

Dosage Form

-

Strength

12MG;75MG

Approval Date

1985-04-25

18793 / 1 View Details

Active Ingredient

CHLORPHENIRAMINE MALEATE; PHENYLPROPANOLAMINE HYDROCHLORIDE

Application Number

18793

Product Number

1

Dosage Form

-

Strength

12MG;75MG

Approval Date

1985-04-25

Regulatory Status

Discontinued

1985

23 Apr

Discontinued Application: 18794

Drug Name

COLD CAPSULE V

Product Number

1

Dosage Form

-

Strength

8MG;75MG

Approval Date

1985-04-23

18794 / 1 View Details

Active Ingredient

CHLORPHENIRAMINE MALEATE; PHENYLPROPANOLAMINE HYDROCHLORIDE

Application Number

18794

Product Number

1

Dosage Form

-

Strength

8MG;75MG

Approval Date

1985-04-23

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 17685

Drug Name

CONRAY 325

Product Number

1

Dosage Form

-

Strength

54.3%

Approval Date

1982-01-01

17685 / 1 View Details

Active Ingredient

IOTHALAMATE SODIUM

Application Number

17685

Product Number

1

Dosage Form

-

Strength

54.3%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 14295

Drug Name

CONRAY 400

Product Number

1

Dosage Form

-

Strength

66.8%

Approval Date

1982-01-01

14295 / 1 View Details

Active Ingredient

IOTHALAMATE SODIUM

Application Number

14295

Product Number

1

Dosage Form

-

Strength

66.8%

Approval Date

1982-01-01

Regulatory Status

Discontinued

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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

2010

01 Mar

Discontinued Application: 21217

Drug Name

EXALGO

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2010-03-01

21217 / 1 View Details

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

21217

Product Number

1

Dosage Form

-

Strength

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

Approval Date

2010-03-01

Regulatory Status

Discontinued

2010

01 Mar

Discontinued Application: 21217

Drug Name

EXALGO

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2010-03-01

21217 / 2 View Details

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

21217

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2010-03-01

Regulatory Status

Discontinued

2010

01 Mar

Discontinued Application: 21217

Drug Name

EXALGO

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2010-03-01

21217 / 3 View Details

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

21217

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2010-03-01

Regulatory Status

Discontinued

2012

24 Aug

Discontinued Application: 21217

Drug Name

EXALGO

Product Number

4

Dosage Form

-

Strength

32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2012-08-24

21217 / 4 View Details

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

21217

Product Number

4

Dosage Form

-

Strength

32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2012-08-24

Regulatory Status

Discontinued

1985

19 Jun

Discontinued Application: 89102

Drug Name

FEMCET

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

1985-06-19

89102 / 1 View Details

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Application Number

89102

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

1985-06-19

Regulatory Status

Discontinued

2009

30 Oct

Discontinued Application: 78907

Drug Name

FENTANYL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 0.2MG BASE

Approval Date

2009-10-30

78907 / 1 View Details

Active Ingredient

FENTANYL CITRATE

Application Number

78907

Product Number

1

Dosage Form

-

Strength

EQ 0.2MG BASE

Approval Date

2009-10-30

Regulatory Status

Discontinued

2009

30 Oct

Discontinued Application: 78907

Drug Name

FENTANYL CITRATE

Product Number

2

Dosage Form

-

Strength

EQ 0.4MG BASE

Approval Date

2009-10-30

78907 / 2 View Details

Active Ingredient

FENTANYL CITRATE

Application Number

78907

Product Number

2

Dosage Form

-

Strength

EQ 0.4MG BASE

Approval Date

2009-10-30

Regulatory Status

Discontinued

2009

30 Oct

Discontinued Application: 78907

Drug Name

FENTANYL CITRATE

Product Number

3

Dosage Form

-

Strength

EQ 0.6MG BASE

Approval Date

2009-10-30

78907 / 3 View Details

Active Ingredient

FENTANYL CITRATE

Application Number

78907

Product Number

3

Dosage Form

-

Strength

EQ 0.6MG BASE

Approval Date

2009-10-30

Regulatory Status

Discontinued

2009

30 Oct

Discontinued Application: 78907

Drug Name

FENTANYL CITRATE

Product Number

4

Dosage Form

-

Strength

EQ 0.8MG BASE

Approval Date

2009-10-30

78907 / 4 View Details

Active Ingredient

FENTANYL CITRATE

Application Number

78907

Product Number

4

Dosage Form

-

Strength

EQ 0.8MG BASE

Approval Date

2009-10-30

Regulatory Status

Discontinued

2009

30 Oct

Discontinued Application: 78907

Drug Name

FENTANYL CITRATE

Product Number

5

Dosage Form

-

Strength

EQ 1.2MG BASE

Approval Date

2009-10-30

78907 / 5 View Details

Active Ingredient

FENTANYL CITRATE

Application Number

78907

Product Number

5

Dosage Form

-

Strength

EQ 1.2MG BASE

Approval Date

2009-10-30

Regulatory Status

Discontinued

2009

30 Oct

Discontinued Application: 78907

Drug Name

FENTANYL CITRATE

Product Number

6

Dosage Form

-

Strength

EQ 1.6MG BASE

Approval Date

2009-10-30

78907 / 6 View Details

Active Ingredient

FENTANYL CITRATE

Application Number

78907

Product Number

6

Dosage Form

-

Strength

EQ 1.6MG BASE

Approval Date

2009-10-30

Regulatory Status

Discontinued

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

Active Ingredient

FENTANYL

Application Number

77154

Product Number

3

Dosage Form

-

Strength

75MCG/HR

Approval Date

2011-02-09

Regulatory Status

RX

1982

01 Jan

Discontinued Application: 16729

Drug Name

FERROUS CITRATE FE 59

Product Number

1

Dosage Form

-

Strength

25uCi/ML

Approval Date

1982-01-01

16729 / 1 View Details

Active Ingredient

FERROUS CITRATE, FE-59

Application Number

16729

Product Number

1

Dosage Form

-

Strength

25uCi/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2002

29 Jan

Discontinued Application: 75658

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2002-01-29

75658 / 1 View Details

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

75658

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2002-01-29

Regulatory Status

Discontinued

2002

29 Jan

Discontinued Application: 75658

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2002-01-29

75658 / 2 View Details

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

75658

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2002-01-29

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 16666

Drug Name

HIPPURAN I 131

Product Number

1

Dosage Form

-

Strength

0.25mCi/ML

Approval Date

1982-01-01

16666 / 1 View Details

Active Ingredient

IODOHIPPURATE SODIUM I-131

Application Number

16666

Product Number

1

Dosage Form

-

Strength

0.25mCi/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1995

01 Jun

Discontinued Application: 40084

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

750MG;7.5MG

Approval Date

1995-06-01

40084 / 1 View Details

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40084

Product Number

1

Dosage Form

-

Strength

750MG;7.5MG

Approval Date

1995-06-01

Regulatory Status

Discontinued

1995

01 Jun

Discontinued Application: 40084

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

500MG;5MG

Approval Date

1995-06-01

40084 / 2 View Details

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40084

Product Number

2

Dosage Form

-

Strength

500MG;5MG

Approval Date

1995-06-01

Regulatory Status

Discontinued

1996

29 Jul

Discontinued Application: 40084

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

660MG;10MG

Approval Date

1996-07-29

40084 / 3 View Details

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40084

Product Number

3

Dosage Form

-

Strength

660MG;10MG

Approval Date

1996-07-29

Regulatory Status

Discontinued

1996

16 Oct

Discontinued Application: 40084

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

4

Dosage Form

-

Strength

650MG;10MG

Approval Date

1996-10-16

40084 / 4 View Details

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40084

Product Number

4

Dosage Form

-

Strength

650MG;10MG

Approval Date

1996-10-16

Regulatory Status

Discontinued

1998

27 Feb

Discontinued Application: 40201

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;7.5MG

Approval Date

1998-02-27

40201 / 1 View Details

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40201

Product Number

1

Dosage Form

-

Strength

500MG;7.5MG

Approval Date

1998-02-27

Regulatory Status

Discontinued

1998

27 Feb

Discontinued Application: 40201

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

500MG;10MG

Approval Date

1998-02-27

40201 / 2 View Details

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40201

Product Number

2

Dosage Form

-

Strength

500MG;10MG

Approval Date

1998-02-27

Regulatory Status

Discontinued

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 View Details

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40400

Product Number

1

Dosage Form

-

Strength

325MG;10MG

Approval Date

2000-07-26

Regulatory Status

RX

2001

27 Jun

Discontinued Application: 40418

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG/15ML;7.5MG/15ML

Approval Date

2001-06-27

40418 / 1 View Details

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40418

Product Number

1

Dosage Form

-

Strength

500MG/15ML;7.5MG/15ML

Approval Date

2001-06-27

Regulatory Status

Discontinued

2003

29 Aug

Discontinued Application: 40508

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG/15ML;10MG/15ML

Approval Date

2003-08-29

40508 / 1 View Details

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40508

Product Number

1

Dosage Form

-

Strength

500MG/15ML;10MG/15ML

Approval Date

2003-08-29

Regulatory Status

Discontinued

1985

19 Jul

Discontinued Application: 88956

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

1985-07-19

88956 / 1 View Details

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

88956

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

1985-07-19

Regulatory Status

Discontinued

1985

09 Aug

Discontinued Application: 89006

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

1985-08-09

89006 / 1 View Details

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

89006

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

1985-08-09

Regulatory Status

Discontinued

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

76855

Product Number

3

Dosage Form

-

Strength

4MG

Approval Date

2007-09-19

Regulatory Status

RX

1984

22 May

Discontinued Application: 87846

Drug Name

IMIPRAMINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1984-05-22

87846 / 2 View Details

Active Ingredient

IMIPRAMINE HYDROCHLORIDE

Application Number

87846

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1984-05-22

Regulatory Status

Discontinued

1984

22 May

Discontinued Application: 87846

Drug Name

IMIPRAMINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

1984-05-22

87846 / 3 View Details

Active Ingredient

IMIPRAMINE HYDROCHLORIDE

Application Number

87846

Product Number

3

Dosage Form

-

Strength

25MG

Approval Date

1984-05-22

Regulatory Status

Discontinued

2019

13 Dec

RX Application: 212024

Drug Name

LEVORPHANOL TARTRATE

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2019-12-13

212024 / 1 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

218850

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2024-12-17

Regulatory Status

RX

1982

08 Jul

Discontinued Application: 87336

Drug Name

LORCET-HD

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

1982-07-08

87336 / 1 View Details

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

87336

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

1982-07-08

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 87075

Drug Name

MD-50

Product Number

1

Dosage Form

-

Strength

50%

Approval Date

1982-01-01

87075 / 1 View Details

Active Ingredient

DIATRIZOATE SODIUM

Application Number

87075

Product Number

1

Dosage Form

-

Strength

50%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 87074

Drug Name

MD-60

Product Number

1

Dosage Form

-

Strength

52%;8%

Approval Date

1982-01-01

87074 / 1 View Details

Active Ingredient

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

Application Number

87074

Product Number

1

Dosage Form

-

Strength

52%;8%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 87073

Drug Name

MD-76

Product Number

1

Dosage Form

-

Strength

66%;10%

Approval Date

1982-01-01

87073 / 1 View Details

Active Ingredient

DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM

Application Number

87073

Product Number

1

Dosage Form

-

Strength

66%;10%

Approval Date

1982-01-01

Regulatory Status

Discontinued

2000

13 Jun

Discontinued Application: 40352

Drug Name

MEPERIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2000-06-13

40352 / 1 View Details

Active Ingredient

MEPERIDINE HYDROCHLORIDE

Application Number

40352

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2000-06-13

Regulatory Status

Discontinued

2000

13 Jun

Discontinued Application: 40352

Drug Name

MEPERIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2000-06-13

40352 / 2 View Details

Active Ingredient

MEPERIDINE HYDROCHLORIDE

Application Number

40352

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2000-06-13

Regulatory Status

Discontinued

1997

12 May

Discontinued Application: 40163

Drug Name

MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1997-05-12

40163 / 1 View Details

Active Ingredient

MEPERIDINE HYDROCHLORIDE

Application Number

40163

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1997-05-12

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 6383

Drug Name

METHADONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

50GM/BOT

Approval Date

1982-01-01

6383 / 2 View Details

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

6383

Product Number

2

Dosage Form

-

Strength

50GM/BOT

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 6383

Drug Name

METHADONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

100GM/BOT

Approval Date

1982-01-01

6383 / 3 View Details

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

6383

Product Number

3

Dosage Form

-

Strength

100GM/BOT

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 6383

Drug Name

METHADONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

500GM/BOT

Approval Date

1982-01-01

6383 / 4 View Details

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

6383

Product Number

4

Dosage Form

-

Strength

500GM/BOT

Approval Date

1982-01-01

Regulatory Status

Discontinued

2004

27 Apr

RX Application: 40517

Drug Name

METHADONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2004-04-27

40517 / 1 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

17116

Product Number

2

Dosage Form

-

Strength

10MG/ML

Approval Date

1982-01-01

Regulatory Status

RX

1993

15 Apr

Discontinued Application: 40050

Drug Name

METHADOSE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1993-04-15

40050 / 1 View Details

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

40050

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1993-04-15

Regulatory Status

Discontinued

1993

15 Apr

Discontinued Application: 40050

Drug Name

METHADOSE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1993-04-15

40050 / 2 View Details

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

40050

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1993-04-15

Regulatory Status

Discontinued

1993

29 Apr

RX Application: 74184

Drug Name

METHADOSE

Product Number

1

Dosage Form

-

Strength

40MG

Approval Date

1993-04-29

74184 / 1 View Details

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 View Details

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 View Details

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

21419

Product Number

2

Dosage Form

-

Strength

10MG/5ML

Approval Date

2002-12-19

Regulatory Status

RX

2003

15 Apr

Discontinued Application: 21475

Drug Name

METHYLIN

Product Number

1

Dosage Form

-

Strength

2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-04-15

21475 / 1 View Details

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

21475

Product Number

1

Dosage Form

-

Strength

2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2003-04-15

Regulatory Status

Discontinued

2003

15 Apr

Discontinued Application: 21475

Drug Name

METHYLIN

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2003-04-15

21475 / 2 View Details

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

21475

Product Number

2

Dosage Form

-

Strength

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

Approval Date

2003-04-15

Regulatory Status

Discontinued

2003

15 Apr

Discontinued Application: 21475

Drug Name

METHYLIN

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2003-04-15

21475 / 3 View Details

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

21475

Product Number

3

Dosage Form

-

Strength

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

Approval Date

2003-04-15

Regulatory Status

Discontinued

2000

09 May

RX Application: 75629

Drug Name

METHYLIN ER

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2000-05-09

75629 / 1 View Details

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 View Details

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 View Details

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 View Details

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 View Details

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

40300

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

1998-11-27

Regulatory Status

RX

2012

28 Dec

Discontinued Application: 202608

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

27MG

Approval Date

2012-12-28

202608 / 1 View Details

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

202608

Product Number

1

Dosage Form

-

Strength

27MG

Approval Date

2012-12-28

Regulatory Status

Discontinued

2012

28 Dec

Discontinued Application: 202608

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

36MG

Approval Date

2012-12-28

202608 / 2 View Details

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

202608

Product Number

2

Dosage Form

-

Strength

36MG

Approval Date

2012-12-28

Regulatory Status

Discontinued

2012

28 Dec

Discontinued Application: 202608

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

54MG

Approval Date

2012-12-28

202608 / 3 View Details

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

202608

Product Number

3

Dosage Form

-

Strength

54MG

Approval Date

2012-12-28

Regulatory Status

Discontinued

2015

29 Sep

RX Application: 203583

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2015-09-29

203583 / 1 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

203583

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2015-09-29

Regulatory Status

RX

1996

03 Jul

Discontinued Application: 20631

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1996-07-03

20631 / 1 View Details

Active Ingredient

MORPHINE SULFATE

Application Number

20631

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

1996-07-03

Regulatory Status

Discontinued

1996

03 Jul

Discontinued Application: 20631

Drug Name

MORPHINE SULFATE

Product Number

2

Dosage Form

-

Strength

2MG/ML

Approval Date

1996-07-03

20631 / 2 View Details

Active Ingredient

MORPHINE SULFATE

Application Number

20631

Product Number

2

Dosage Form

-

Strength

2MG/ML

Approval Date

1996-07-03

Regulatory Status

Discontinued

2003

31 Jul

RX Application: 76412

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2003-07-31

76412 / 1 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

Active Ingredient

NALTREXONE HYDROCHLORIDE

Application Number

76264

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2002-03-22

Regulatory Status

RX

1982

01 Jan

Discontinued Application: 17454

Drug Name

OSTEOSCAN

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

1982-01-01

17454 / 1 View Details

Active Ingredient

TECHNETIUM TC-99M ETIDRONATE KIT

Application Number

17454

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

1982-01-01

Regulatory Status

Discontinued

1983

07 Dec

RX Application: 87463

Drug Name

OXYCET

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

1983-12-07

87463 / 1 View Details

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

87463

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

1983-12-07

Regulatory Status

RX

1998

04 Aug

Discontinued Application: 40257

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

1998-08-04

40257 / 1 View Details

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

40257

Product Number

1

Dosage Form

-

Strength

500MG;5MG

Approval Date

1998-08-04

Regulatory Status

Discontinued

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 View Details

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 View Details

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

Discontinued Application: 40550

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG;7.5MG

Approval Date

2004-06-30

40550 / 1 View Details

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

40550

Product Number

1

Dosage Form

-

Strength

500MG;7.5MG

Approval Date

2004-06-30

Regulatory Status

Discontinued

2004

30 Jun

Discontinued Application: 40550

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

650MG;10MG

Approval Date

2004-06-30

40550 / 2 View Details

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

40550

Product Number

2

Dosage Form

-

Strength

650MG;10MG

Approval Date

2004-06-30

Regulatory Status

Discontinued

2006

29 Sep

Discontinued Application: 40680

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG/5ML;5MG/5ML

Approval Date

2006-09-29

40680 / 1 View Details

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

40680

Product Number

1

Dosage Form

-

Strength

325MG/5ML;5MG/5ML

Approval Date

2006-09-29

Regulatory Status

Discontinued

2004

30 Jun

RX Application: 76758

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2004-06-30

76758 / 1 View Details

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 View Details

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 View Details

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 View Details

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 View Details

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

76758

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2021-10-12

Regulatory Status

RX

-

Unclassified Application: 77822

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

-

77822 / 1 View Details

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

77822

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 77822

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

-

77822 / 2 View Details

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

77822

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 77822

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

-

77822 / 3 View Details

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

77822

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

-

Regulatory Status

Unclassified

-

Unclassified Application: 77822

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

-

77822 / 4 View Details

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

77822

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

-

Regulatory Status

Unclassified

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 View Details

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 View Details

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

210758

Product Number

2

Dosage Form

-

Strength

100MG/5ML

Approval Date

2018-04-30

Regulatory Status

RX

2013

25 Apr

Discontinued Application: 202321

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2013-04-25

202321 / 1 View Details

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

202321

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2013-04-25

Regulatory Status

Discontinued

2013

25 Apr

Discontinued Application: 202321

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2013-04-25

202321 / 2 View Details

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

202321

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2013-04-25

Regulatory Status

Discontinued

2014

27 Jun

Discontinued Application: 202946

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2014-06-27

202946 / 1 View Details

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

202946

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2014-06-27

Regulatory Status

Discontinued

2014

27 Jun

Discontinued Application: 202946

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2014-06-27

202946 / 2 View Details

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

202946

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

2014-06-27

Regulatory Status

Discontinued

2014

27 Jun

Discontinued Application: 202946

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2014-06-27

202946 / 3 View Details

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

202946

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2014-06-27

Regulatory Status

Discontinued

2014

27 Jun

Discontinued Application: 202946

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2014-06-27

202946 / 4 View Details

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

202946

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2014-06-27

Regulatory Status

Discontinued

2014

27 Jun

Discontinued Application: 202946

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2014-06-27

202946 / 5 View Details

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

202946

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2014-06-27

Regulatory Status

Discontinued

2014

27 Jun

Discontinued Application: 202946

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2014-06-27

202946 / 6 View Details

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

202946

Product Number

6

Dosage Form

-

Strength

30MG

Approval Date

2014-06-27

Regulatory Status

Discontinued

2014

27 Jun

Discontinued Application: 202946

Drug Name

OXYMORPHONE HYDROCHLORIDE

Product Number

7

Dosage Form

-

Strength

40MG

Approval Date

2014-06-27

202946 / 7 View Details

Active Ingredient

OXYMORPHONE HYDROCHLORIDE

Application Number

202946

Product Number

7

Dosage Form

-

Strength

40MG

Approval Date

2014-06-27

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 18012

Drug Name

PAMELOR

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/5ML

Approval Date

1982-01-01

18012 / 1 View Details

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

18012

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 18013

Drug Name

PAMELOR

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1982-01-01

18013 / 1 View Details

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

18013

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 18013

Drug Name

PAMELOR

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

1982-01-01

18013 / 2 View Details

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

18013

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 18013

Drug Name

PAMELOR

Product Number

3

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

1982-01-01

18013 / 3 View Details

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

18013

Product Number

3

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 18013

Drug Name

PAMELOR

Product Number

4

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1982-01-01

18013 / 4 View Details

Active Ingredient

NORTRIPTYLINE HYDROCHLORIDE

Application Number

18013

Product Number

4

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1982-01-01

Regulatory Status

Discontinued

2001

30 Mar

Discontinued Application: 75726

Drug Name

PEMOLINE

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2001-03-30

75726 / 1 View Details

Active Ingredient

PEMOLINE

Application Number

75726

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2001-03-30

Regulatory Status

Discontinued

2001

30 Mar

Discontinued Application: 75726

Drug Name

PEMOLINE

Product Number

2

Dosage Form

-

Strength

37.5MG

Approval Date

2001-03-30

75726 / 2 View Details

Active Ingredient

PEMOLINE

Application Number

75726

Product Number

2

Dosage Form

-

Strength

37.5MG

Approval Date

2001-03-30

Regulatory Status

Discontinued

2001

30 Mar

Discontinued Application: 75726

Drug Name

PEMOLINE

Product Number

3

Dosage Form

-

Strength

18.75MG

Approval Date

2001-03-30

75726 / 3 View Details

Active Ingredient

PEMOLINE

Application Number

75726

Product Number

3

Dosage Form

-

Strength

18.75MG

Approval Date

2001-03-30

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 17551

Drug Name

PERCHLORACAP

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

17551 / 1 View Details

Active Ingredient

POTASSIUM PERCHLORATE

Application Number

17551

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

26 May

Discontinued Application: 87214

Drug Name

PHENDIMETRAZINE TARTRATE

Product Number

1

Dosage Form

-

Strength

105MG

Approval Date

1982-05-26

87214 / 1 View Details

Active Ingredient

PHENDIMETRAZINE TARTRATE

Application Number

87214

Product Number

1

Dosage Form

-

Strength

105MG

Approval Date

1982-05-26

Regulatory Status

Discontinued

1982

16 Aug

Discontinued Application: 88020

Drug Name

PHENDIMETRAZINE TARTRATE

Product Number

1

Dosage Form

-

Strength

105MG

Approval Date

1982-08-16

88020 / 1 View Details

Active Ingredient

PHENDIMETRAZINE TARTRATE

Application Number

88020

Product Number

1

Dosage Form

-

Strength

105MG

Approval Date

1982-08-16

Regulatory Status

Discontinued

1982

16 Aug

Discontinued Application: 88028

Drug Name

PHENDIMETRAZINE TARTRATE

Product Number

1

Dosage Form

-

Strength

105MG

Approval Date

1982-08-16

88028 / 1 View Details

Active Ingredient

PHENDIMETRAZINE TARTRATE

Application Number

88028

Product Number

1

Dosage Form

-

Strength

105MG

Approval Date

1982-08-16

Regulatory Status

Discontinued

1982

13 Sep

Discontinued Application: 88062

Drug Name

PHENDIMETRAZINE TARTRATE

Product Number

1

Dosage Form

-

Strength

105MG

Approval Date

1982-09-13

88062 / 1 View Details

Active Ingredient

PHENDIMETRAZINE TARTRATE

Application Number

88062

Product Number

1

Dosage Form

-

Strength

105MG

Approval Date

1982-09-13

Regulatory Status

Discontinued

1982

10 Sep

Discontinued Application: 88063

Drug Name

PHENDIMETRAZINE TARTRATE

Product Number

1

Dosage Form

-

Strength

105MG

Approval Date

1982-09-10

88063 / 1 View Details

Active Ingredient

PHENDIMETRAZINE TARTRATE

Application Number

88063

Product Number

1

Dosage Form

-

Strength

105MG

Approval Date

1982-09-10

Regulatory Status

Discontinued

1982

18 Oct

Discontinued Application: 88111

Drug Name

PHENDIMETRAZINE TARTRATE

Product Number

1

Dosage Form

-

Strength

105MG

Approval Date

1982-10-18

88111 / 1 View Details

Active Ingredient

PHENDIMETRAZINE TARTRATE

Application Number

88111

Product Number

1

Dosage Form

-

Strength

105MG

Approval Date

1982-10-18

Regulatory Status

Discontinued

2022

10 May

RX Application: 212226

Drug Name

POSACONAZOLE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2022-05-10

212226 / 1 View Details

Active Ingredient

POSACONAZOLE

Application Number

212226

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2022-05-10

Regulatory Status

RX

2001

02 Feb

Discontinued Application: 75738

Drug Name

PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

2001-02-02

75738 / 1 View Details

Active Ingredient

ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE

Application Number

75738

Product Number

1

Dosage Form

-

Strength

650MG;100MG

Approval Date

2001-02-02

Regulatory Status

Discontinued

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 View Details

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 View Details

Active Ingredient

PRUCALOPRIDE SUCCINATE

Application Number

219193

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2025-06-24

Regulatory Status

RX

1985

18 Mar

Discontinued Application: 18843

Drug Name

PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE

Product Number

1

Dosage Form

-

Strength

12MG;120MG

Approval Date

1985-03-18

18843 / 1 View Details

Active Ingredient

CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

18843

Product Number

1

Dosage Form

-

Strength

12MG;120MG

Approval Date

1985-03-18

Regulatory Status

Discontinued

1985

20 Mar

Discontinued Application: 18844

Drug Name

PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE

Product Number

1

Dosage Form

-

Strength

8MG;120MG

Approval Date

1985-03-20

18844 / 1 View Details

Active Ingredient

CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

18844

Product Number

1

Dosage Form

-

Strength

8MG;120MG

Approval Date

1985-03-20

Regulatory Status

Discontinued

1982

01 Jan

RX Application: 18163

Drug Name

RESTORIL

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1982-01-01

18163 / 1 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

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 View Details

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

21011

Product Number

3

Dosage Form

-

Strength

5MG

Approval Date

2009-05-15

Regulatory Status

RX

1982

01 Jan

Discontinued Application: 17098

Drug Name

SELENOMETHIONINE SE 75

Product Number

1

Dosage Form

-

Strength

100uCi/ML

Approval Date

1982-01-01

17098 / 1 View Details

Active Ingredient

SELENOMETHIONINE SE-75

Application Number

17098

Product Number

1

Dosage Form

-

Strength

100uCi/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 17725

Drug Name

SODIUM PERTECHNETATE TC 99M

Product Number

1

Dosage Form

-

Strength

10-60mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17725 / 1 View Details

Active Ingredient

TECHNETIUM TC-99M SODIUM PERTECHNETATE

Application Number

17725

Product Number

1

Dosage Form

-

Strength

10-60mCi/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 11777

Drug Name

SODIUM PHOSPHATE P 32

Product Number

1

Dosage Form

-

Strength

0.67mCi/ML

Approval Date

1982-01-01

11777 / 1 View Details

Active Ingredient

SODIUM PHOSPHATE P-32

Application Number

11777

Product Number

1

Dosage Form

-

Strength

0.67mCi/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 11777

Drug Name

SODIUM PHOSPHATE P 32

Product Number

2

Dosage Form

-

Strength

1.5mCi/VIAL

Approval Date

1982-01-01

11777 / 2 View Details

Active Ingredient

SODIUM PHOSPHATE P-32

Application Number

11777

Product Number

2

Dosage Form

-

Strength

1.5mCi/VIAL

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 87193

Drug Name

SOMOPHYLLIN-CRT

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

87193 / 1 View Details

Active Ingredient

THEOPHYLLINE

Application Number

87193

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 87194

Drug Name

SOMOPHYLLIN-CRT

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

87194 / 1 View Details

Active Ingredient

THEOPHYLLINE

Application Number

87194

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1982-01-01

Regulatory Status

Discontinued

1985

27 Feb

Discontinued Application: 87763

Drug Name

SOMOPHYLLIN-CRT

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1985-02-27

87763 / 1 View Details

Active Ingredient

THEOPHYLLINE

Application Number

87763

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1985-02-27

Regulatory Status

Discontinued

1985

27 Feb

Discontinued Application: 88382

Drug Name

SOMOPHYLLIN-CRT

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1985-02-27

88382 / 1 View Details

Active Ingredient

THEOPHYLLINE

Application Number

88382

Product Number

1

Dosage Form

-

Strength

200MG

Approval Date

1985-02-27

Regulatory Status

Discontinued

1985

27 Feb

Discontinued Application: 88383

Drug Name

SOMOPHYLLIN-CRT

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1985-02-27

88383 / 1 View Details

Active Ingredient

THEOPHYLLINE

Application Number

88383

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

1985-02-27

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 17059

Drug Name

TECHNECOLL

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

1982-01-01

17059 / 1 View Details

Active Ingredient

TECHNETIUM TC-99M SULFUR COLLOID KIT

Application Number

17059

Product Number

1

Dosage Form

-

Strength

N/A

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 17724

Drug Name

TECHNETIUM TC 99M SULFUR COLLOID

Product Number

1

Dosage Form

-

Strength

3mCi/ML

Approval Date

1982-01-01

17724 / 1 View Details

Active Ingredient

TECHNETIUM TC-99M SULFUR COLLOID

Application Number

17724

Product Number

1

Dosage Form

-

Strength

3mCi/ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1990

15 May

Discontinued Application: 89405

Drug Name

TENCON

Product Number

1

Dosage Form

-

Strength

650MG;50MG

Approval Date

1990-05-15

89405 / 1 View Details

Active Ingredient

ACETAMINOPHEN; BUTALBITAL

Application Number

89405

Product Number

1

Dosage Form

-

Strength

650MG;50MG

Approval Date

1990-05-15

Regulatory Status

Discontinued

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 View Details

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 View Details

Active Ingredient

TOFACITINIB CITRATE

Application Number

219395

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2026-06-03

Regulatory Status

RX

1984

22 May

Discontinued Application: 87846

Drug Name

TOFRANIL

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1984-05-22

87846 / 1 View Details

Active Ingredient

IMIPRAMINE HYDROCHLORIDE

Application Number

87846

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1984-05-22

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 17090

Drug Name

TOFRANIL-PM

Product Number

1

Dosage Form

-

Strength

EQ 75MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17090 / 1 View Details

Active Ingredient

IMIPRAMINE PAMOATE

Application Number

17090

Product Number

1

Dosage Form

-

Strength

EQ 75MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 17090

Drug Name

TOFRANIL-PM

Product Number

2

Dosage Form

-

Strength

EQ 150MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17090 / 2 View Details

Active Ingredient

IMIPRAMINE PAMOATE

Application Number

17090

Product Number

2

Dosage Form

-

Strength

EQ 150MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 17090

Drug Name

TOFRANIL-PM

Product Number

3

Dosage Form

-

Strength

EQ 125MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17090 / 3 View Details

Active Ingredient

IMIPRAMINE PAMOATE

Application Number

17090

Product Number

3

Dosage Form

-

Strength

EQ 125MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 17090

Drug Name

TOFRANIL-PM

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1982-01-01

17090 / 4 View Details

Active Ingredient

IMIPRAMINE PAMOATE

Application Number

17090

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1982-01-01

Regulatory Status

Discontinued

2002

25 Jun

Discontinued Application: 75983

Drug Name

TRAMADOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2002-06-25

75983 / 1 View Details

Active Ingredient

TRAMADOL HYDROCHLORIDE

Application Number

75983

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2002-06-25

Regulatory Status

Discontinued

1985

19 Jun

Discontinued Application: 89023

Drug Name

TRIAD

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

1985-06-19

89023 / 1 View Details

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Application Number

89023

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

1985-06-19

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 16783

Drug Name

VASCORAY

Product Number

1

Dosage Form

-

Strength

52%;26%

Approval Date

1982-01-01

16783 / 1 View Details

Active Ingredient

IOTHALAMATE MEGLUMINE; IOTHALAMATE SODIUM

Application Number

16783

Product Number

1

Dosage Form

-

Strength

52%;26%

Approval Date

1982-01-01

Regulatory Status

Discontinued

2021

28 Jul

Discontinued Application: 212626

Drug Name

VIGABATRIN

Product Number

1

Dosage Form

-

Strength

500MG/PACKET

Approval Date

2021-07-28

212626 / 1 View Details

Active Ingredient

VIGABATRIN

Application Number

212626

Product Number

1

Dosage Form

-

Strength

500MG/PACKET

Approval Date

2021-07-28

Regulatory Status

Discontinued

2014

11 Mar

Discontinued Application: 204031

Drug Name

XARTEMIS XR

Product Number

1

Dosage Form

-

Strength

325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2014-03-11

204031 / 1 View Details

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

204031

Product Number

1

Dosage Form

-

Strength

325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2014-03-11

Regulatory Status

Discontinued

1982

01 Jan

Discontinued Application: 17262

Drug Name

XENEISOL

Product Number

2

Dosage Form

-

Strength

18-25mCi/AMP

Approval Date

1982-01-01

17262 / 2 View Details

Active Ingredient

XENON XE-133

Application Number

17262

Product Number

2

Dosage Form

-

Strength

18-25mCi/AMP

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982

01 Oct

Discontinued Application: 18536

Drug Name

XENON XE 127

Product Number

1

Dosage Form

-

Strength

5mCi/VIAL

Approval Date

1982-10-01

18536 / 1 View Details

Active Ingredient

XENON XE-127

Application Number

18536

Product Number

1

Dosage Form

-

Strength

5mCi/VIAL

Approval Date

1982-10-01

Regulatory Status

Discontinued

1982

01 Oct

Discontinued Application: 18536

Drug Name

XENON XE 127

Product Number

2

Dosage Form

-

Strength

10mCi/VIAL

Approval Date

1982-10-01

18536 / 2 View Details

Active Ingredient

XENON XE-127

Application Number

18536

Product Number

2

Dosage Form

-

Strength

10mCi/VIAL

Approval Date

1982-10-01

Regulatory Status

Discontinued

Mallinckrodt Pharmaceuticals
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