Alvogen
FDA Approved Drugs

Alvogen

FDA Approved Drugs Database

FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.

RX Discontinued Unclassified
  • Total Records 133
  • Latest Approval Date Mar 06, 2023
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
133
View
Unclassified
6
View
Discontinued
69
View
RX
58
View
Company Overview

Company

Alvogen

Country

U.S.A

Website

Visit Website

Email

halldor.kristmannsson@alvogen.com

Social Profiles

Company Snapshot

Alvogen

Alvogen US10 Bloomfield AvenuePine BrookNJ 07058 U.S.A.

U.S.A

www.alvogen.com/ halldor.kristmannsson@alvogen.com View on Map
FDA Approved Drug Records ( 133 records )
2012
21 Jun
RX Application: 203853

Drug Name

ACETYLCYSTEINE

Product Number

1

Dosage Form

-

Strength

20%

Approval Date

2012-06-21

203853 / 1

Active Ingredient

ACETYLCYSTEINE

Application Number

203853

Product Number

1

Dosage Form

-

Strength

20%

Approval Date

2012-06-21

Regulatory Status

RX

2014
11 Feb
RX Application: 204674

Drug Name

ACETYLCYSTEINE

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

2014-02-11

204674 / 1

Active Ingredient

ACETYLCYSTEINE

Application Number

204674

Product Number

1

Dosage Form

-

Strength

10%

Approval Date

2014-02-11

Regulatory Status

RX

2019
04 Oct
RX Application: 211939

Drug Name

BONSITY

Product Number

1

Dosage Form

-

Strength

0.56MG/2.24ML (0.25MG/ML)

Approval Date

2019-10-04

211939 / 1

Active Ingredient

TERIPARATIDE

Application Number

211939

Product Number

1

Dosage Form

-

Strength

0.56MG/2.24ML (0.25MG/ML)

Approval Date

2019-10-04

Regulatory Status

RX

2019
26 Apr
Discontinued Application: 206002

Drug Name

BOSENTAN

Product Number

1

Dosage Form

-

Strength

62.5MG

Approval Date

2019-04-26

206002 / 1

Active Ingredient

BOSENTAN

Application Number

206002

Product Number

1

Dosage Form

-

Strength

62.5MG

Approval Date

2019-04-26

Regulatory Status

Discontinued

2019
26 Apr
Discontinued Application: 206002

Drug Name

BOSENTAN

Product Number

2

Dosage Form

-

Strength

125MG

Approval Date

2019-04-26

206002 / 2

Active Ingredient

BOSENTAN

Application Number

206002

Product Number

2

Dosage Form

-

Strength

125MG

Approval Date

2019-04-26

Regulatory Status

Discontinued

2019
24 Jan
RX Application: 205954

Drug Name

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE;EQ 0.5MG BASE

Approval Date

2019-01-24

205954 / 1

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Application Number

205954

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE;EQ 0.5MG BASE

Approval Date

2019-01-24

Regulatory Status

RX

2019
24 Jan
RX Application: 205954

Drug Name

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE;EQ 1MG BASE

Approval Date

2019-01-24

205954 / 2

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Application Number

205954

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE;EQ 1MG BASE

Approval Date

2019-01-24

Regulatory Status

RX

2019
24 Jan
RX Application: 205954

Drug Name

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 8MG BASE;EQ 2MG BASE

Approval Date

2019-01-24

205954 / 3

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Application Number

205954

Product Number

3

Dosage Form

-

Strength

EQ 8MG BASE;EQ 2MG BASE

Approval Date

2019-01-24

Regulatory Status

RX

2019
24 Jan
RX Application: 205954

Drug Name

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 12MG BASE;EQ 3MG BASE

Approval Date

2019-01-24

205954 / 4

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Application Number

205954

Product Number

4

Dosage Form

-

Strength

EQ 12MG BASE;EQ 3MG BASE

Approval Date

2019-01-24

Regulatory Status

RX

2015
30 Oct
Discontinued Application: 205120

Drug Name

BUTALBITAL AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;50MG

Approval Date

2015-10-30

205120 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL

Application Number

205120

Product Number

1

Dosage Form

-

Strength

325MG;50MG

Approval Date

2015-10-30

Regulatory Status

Discontinued

2017
05 Jun
Discontinued Application: 207635

Drug Name

BUTALBITAL AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

300MG;50MG

Approval Date

2017-06-05

207635 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL

Application Number

207635

Product Number

1

Dosage Form

-

Strength

300MG;50MG

Approval Date

2017-06-05

Regulatory Status

Discontinued

2017
10 Jan
Discontinued Application: 204984

Drug Name

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

2017-01-10

204984 / 1

Active Ingredient

ACETAMINOPHEN; BUTALBITAL; CAFFEINE

Application Number

204984

Product Number

1

Dosage Form

-

Strength

325MG;50MG;40MG

Approval Date

2017-01-10

Regulatory Status

Discontinued

2016
08 Jan
Discontinued Application: 204291

Drug Name

CARBIDOPA

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2016-01-08

204291 / 1

Active Ingredient

CARBIDOPA

Application Number

204291

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2016-01-08

Regulatory Status

Discontinued

1997
21 Jul
Discontinued Application: 20519

Drug Name

CICLOPIROX

Product Number

1

Dosage Form

-

Strength

0.77% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-07-21

20519 / 1

Active Ingredient

CICLOPIROX

Application Number

20519

Product Number

1

Dosage Form

-

Strength

0.77% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1997-07-21

Regulatory Status

Discontinued

2016
07 Jan
Discontinued Application: 205429

Drug Name

DAPSONE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2016-01-07

205429 / 1

Active Ingredient

DAPSONE

Application Number

205429

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2016-01-07

Regulatory Status

Discontinued

2016
07 Jan
Discontinued Application: 205429

Drug Name

DAPSONE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2016-01-07

205429 / 2

Active Ingredient

DAPSONE

Application Number

205429

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2016-01-07

Regulatory Status

Discontinued

1983
28 Nov
RX Application: 88481

Drug Name

DEXAMETHASONE

Product Number

1

Dosage Form

-

Strength

6MG

Approval Date

1983-11-28

88481 / 1

Active Ingredient

DEXAMETHASONE

Application Number

88481

Product Number

1

Dosage Form

-

Strength

6MG

Approval Date

1983-11-28

Regulatory Status

RX

1983
28 Apr
RX Application: 88481

Drug Name

DEXAMETHASONE

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

1983-04-28

88481 / 2

Active Ingredient

DEXAMETHASONE

Application Number

88481

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

1983-04-28

Regulatory Status

RX

1983
28 Apr
RX Application: 88481

Drug Name

DEXAMETHASONE

Product Number

3

Dosage Form

-

Strength

0.75MG

Approval Date

1983-04-28

88481 / 3

Active Ingredient

DEXAMETHASONE

Application Number

88481

Product Number

3

Dosage Form

-

Strength

0.75MG

Approval Date

1983-04-28

Regulatory Status

RX

1983
28 Apr
RX Application: 88481

Drug Name

DEXAMETHASONE

Product Number

4

Dosage Form

-

Strength

4MG

Approval Date

1983-04-28

88481 / 4

Active Ingredient

DEXAMETHASONE

Application Number

88481

Product Number

4

Dosage Form

-

Strength

4MG

Approval Date

1983-04-28

Regulatory Status

RX

2017
28 Jul
RX Application: 207388

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

2017-07-28

207388 / 1

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

207388

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2017-07-28

Regulatory Status

RX

2017
28 Jul
RX Application: 207388

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

2017-07-28

207388 / 2

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

207388

Product Number

2

Dosage Form

-

Strength

1.875MG;1.875MG;1.875MG;1.875MG

Approval Date

2017-07-28

Regulatory Status

RX

2017
28 Jul
RX Application: 207388

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

2017-07-28

207388 / 3

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

207388

Product Number

3

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2017-07-28

Regulatory Status

RX

2017
28 Jul
RX Application: 207388

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

2017-07-28

207388 / 4

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

207388

Product Number

4

Dosage Form

-

Strength

3.125MG;3.125MG;3.125MG;3.125MG

Approval Date

2017-07-28

Regulatory Status

RX

2017
28 Jul
RX Application: 207388

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

2017-07-28

207388 / 5

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

207388

Product Number

5

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG

Approval Date

2017-07-28

Regulatory Status

RX

2017
28 Jul
RX Application: 207388

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

6

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2017-07-28

207388 / 6

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

207388

Product Number

6

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2017-07-28

Regulatory Status

RX

2017
28 Jul
RX Application: 207388

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

2017-07-28

207388 / 7

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

207388

Product Number

7

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2017-07-28

Regulatory Status

RX

2013
08 Aug
RX Application: 91681

Drug Name

DISULFIRAM

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2013-08-08

91681 / 1

Active Ingredient

DISULFIRAM

Application Number

91681

Product Number

1

Dosage Form

-

Strength

250MG

Approval Date

2013-08-08

Regulatory Status

RX

1990
31 Jul
Discontinued Application: 63067

Drug Name

DYNACIN

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1990-07-31

63067 / 1

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

63067

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1990-07-31

Regulatory Status

Discontinued

1999
15 Sep
Discontinued Application: 63067

Drug Name

DYNACIN

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

1999-09-15

63067 / 2

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

63067

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

1999-09-15

Regulatory Status

Discontinued

1990
14 Aug
Discontinued Application: 63067

Drug Name

DYNACIN

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1990-08-14

63067 / 3

Active Ingredient

MINOCYCLINE HYDROCHLORIDE

Application Number

63067

Product Number

3

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

1990-08-14

Regulatory Status

Discontinued

2018
24 Jul
Discontinued Application: 205709

Drug Name

ETHACRYNIC ACID

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2018-07-24

205709 / 1

Active Ingredient

ETHACRYNIC ACID

Application Number

205709

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2018-07-24

Regulatory Status

Discontinued

2016
11 Jan
Discontinued Application: 204595

Drug Name

FELBAMATE

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2016-01-11

204595 / 1

Active Ingredient

FELBAMATE

Application Number

204595

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2016-01-11

Regulatory Status

Discontinued

2016
11 Jan
Discontinued Application: 204595

Drug Name

FELBAMATE

Product Number

2

Dosage Form

-

Strength

600MG

Approval Date

2016-01-11

204595 / 2

Active Ingredient

FELBAMATE

Application Number

204595

Product Number

2

Dosage Form

-

Strength

600MG

Approval Date

2016-01-11

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 17373

Drug Name

FLUOCINONIDE

Product Number

1

Dosage Form

-

Strength

0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

17373 / 1

Active Ingredient

FLUOCINONIDE

Application Number

17373

Product Number

1

Dosage Form

-

Strength

0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

2020
21 Jan
RX Application: 206986

Drug Name

HYDROCODONE BITARTRATE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2020-01-21

206986 / 1

Active Ingredient

HYDROCODONE BITARTRATE

Application Number

206986

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2020-01-21

Regulatory Status

RX

2020
21 Jan
RX Application: 206986

Drug Name

HYDROCODONE BITARTRATE

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2020-01-21

206986 / 2

Active Ingredient

HYDROCODONE BITARTRATE

Application Number

206986

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2020-01-21

Regulatory Status

RX

2020
21 Jan
RX Application: 206986

Drug Name

HYDROCODONE BITARTRATE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2020-01-21

206986 / 3

Active Ingredient

HYDROCODONE BITARTRATE

Application Number

206986

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2020-01-21

Regulatory Status

RX

2020
21 Jan
RX Application: 206986

Drug Name

HYDROCODONE BITARTRATE

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2020-01-21

206986 / 4

Active Ingredient

HYDROCODONE BITARTRATE

Application Number

206986

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2020-01-21

Regulatory Status

RX

2020
21 Jan
RX Application: 206986

Drug Name

HYDROCODONE BITARTRATE

Product Number

5

Dosage Form

-

Strength

40MG

Approval Date

2020-01-21

206986 / 5

Active Ingredient

HYDROCODONE BITARTRATE

Application Number

206986

Product Number

5

Dosage Form

-

Strength

40MG

Approval Date

2020-01-21

Regulatory Status

RX

2020
21 Jan
RX Application: 206986

Drug Name

HYDROCODONE BITARTRATE

Product Number

6

Dosage Form

-

Strength

50MG

Approval Date

2020-01-21

206986 / 6

Active Ingredient

HYDROCODONE BITARTRATE

Application Number

206986

Product Number

6

Dosage Form

-

Strength

50MG

Approval Date

2020-01-21

Regulatory Status

RX

2021
01 Mar
RX Application: 208269

Drug Name

HYDROCODONE BITARTRATE

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2021-03-01

208269 / 1

Active Ingredient

HYDROCODONE BITARTRATE

Application Number

208269

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2021-03-01

Regulatory Status

RX

2021
01 Mar
RX Application: 208269

Drug Name

HYDROCODONE BITARTRATE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2021-03-01

208269 / 2

Active Ingredient

HYDROCODONE BITARTRATE

Application Number

208269

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2021-03-01

Regulatory Status

RX

2021
01 Mar
RX Application: 208269

Drug Name

HYDROCODONE BITARTRATE

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2021-03-01

208269 / 3

Active Ingredient

HYDROCODONE BITARTRATE

Application Number

208269

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2021-03-01

Regulatory Status

RX

2021
01 Mar
RX Application: 208269

Drug Name

HYDROCODONE BITARTRATE

Product Number

4

Dosage Form

-

Strength

60MG

Approval Date

2021-03-01

208269 / 4

Active Ingredient

HYDROCODONE BITARTRATE

Application Number

208269

Product Number

4

Dosage Form

-

Strength

60MG

Approval Date

2021-03-01

Regulatory Status

RX

2021
01 Mar
RX Application: 208269

Drug Name

HYDROCODONE BITARTRATE

Product Number

5

Dosage Form

-

Strength

80MG

Approval Date

2021-03-01

208269 / 5

Active Ingredient

HYDROCODONE BITARTRATE

Application Number

208269

Product Number

5

Dosage Form

-

Strength

80MG

Approval Date

2021-03-01

Regulatory Status

RX

2021
01 Mar
RX Application: 208269

Drug Name

HYDROCODONE BITARTRATE

Product Number

6

Dosage Form

-

Strength

100MG

Approval Date

2021-03-01

208269 / 6

Active Ingredient

HYDROCODONE BITARTRATE

Application Number

208269

Product Number

6

Dosage Form

-

Strength

100MG

Approval Date

2021-03-01

Regulatory Status

RX

2021
01 Mar
RX Application: 208269

Drug Name

HYDROCODONE BITARTRATE

Product Number

7

Dosage Form

-

Strength

120MG

Approval Date

2021-03-01

208269 / 7

Active Ingredient

HYDROCODONE BITARTRATE

Application Number

208269

Product Number

7

Dosage Form

-

Strength

120MG

Approval Date

2021-03-01

Regulatory Status

RX

2018
08 Nov
Discontinued Application: 208540

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

300MG;5MG

Approval Date

2018-11-08

208540 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

208540

Product Number

1

Dosage Form

-

Strength

300MG;5MG

Approval Date

2018-11-08

Regulatory Status

Discontinued

2018
08 Nov
Discontinued Application: 208540

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

300MG;7.5MG

Approval Date

2018-11-08

208540 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

208540

Product Number

2

Dosage Form

-

Strength

300MG;7.5MG

Approval Date

2018-11-08

Regulatory Status

Discontinued

2018
08 Nov
Discontinued Application: 208540

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

300MG;10MG

Approval Date

2018-11-08

208540 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

208540

Product Number

3

Dosage Form

-

Strength

300MG;10MG

Approval Date

2018-11-08

Regulatory Status

Discontinued

2018
24 Oct
Discontinued Application: 209958

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;2.5MG

Approval Date

2018-10-24

209958 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

209958

Product Number

1

Dosage Form

-

Strength

325MG;2.5MG

Approval Date

2018-10-24

Regulatory Status

Discontinued

2018
24 Oct
Discontinued Application: 209958

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;5MG

Approval Date

2018-10-24

209958 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

209958

Product Number

2

Dosage Form

-

Strength

325MG;5MG

Approval Date

2018-10-24

Regulatory Status

Discontinued

2018
24 Oct
Discontinued Application: 209958

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2018-10-24

209958 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

209958

Product Number

3

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2018-10-24

Regulatory Status

Discontinued

2018
24 Oct
Discontinued Application: 209958

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

4

Dosage Form

-

Strength

325MG;10MG

Approval Date

2018-10-24

209958 / 4

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

209958

Product Number

4

Dosage Form

-

Strength

325MG;10MG

Approval Date

2018-10-24

Regulatory Status

Discontinued

-
Unclassified Application: 212763

Drug Name

IBRUTINIB

Product Number

1

Dosage Form

-

Strength

140MG

Approval Date

-

212763 / 1

Active Ingredient

IBRUTINIB

Application Number

212763

Product Number

1

Dosage Form

-

Strength

140MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 212763

Drug Name

IBRUTINIB

Product Number

2

Dosage Form

-

Strength

280MG

Approval Date

-

212763 / 2

Active Ingredient

IBRUTINIB

Application Number

212763

Product Number

2

Dosage Form

-

Strength

280MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 212763

Drug Name

IBRUTINIB

Product Number

3

Dosage Form

-

Strength

420MG

Approval Date

-

212763 / 3

Active Ingredient

IBRUTINIB

Application Number

212763

Product Number

3

Dosage Form

-

Strength

420MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 212763

Drug Name

IBRUTINIB

Product Number

4

Dosage Form

-

Strength

560MG

Approval Date

-

212763 / 4

Active Ingredient

IBRUTINIB

Application Number

212763

Product Number

4

Dosage Form

-

Strength

560MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 214498

Drug Name

IBRUTINIB

Product Number

1

Dosage Form

-

Strength

70MG

Approval Date

-

214498 / 1

Active Ingredient

IBRUTINIB

Application Number

214498

Product Number

1

Dosage Form

-

Strength

70MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 214498

Drug Name

IBRUTINIB

Product Number

2

Dosage Form

-

Strength

140MG

Approval Date

-

214498 / 2

Active Ingredient

IBRUTINIB

Application Number

214498

Product Number

2

Dosage Form

-

Strength

140MG

Approval Date

-

Regulatory Status

Unclassified

2022
31 Aug
RX Application: 210480

Drug Name

LENALIDOMIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2022-08-31

210480 / 1

Active Ingredient

LENALIDOMIDE

Application Number

210480

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2022-08-31

Regulatory Status

RX

2022
31 Aug
RX Application: 210480

Drug Name

LENALIDOMIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2022-08-31

210480 / 2

Active Ingredient

LENALIDOMIDE

Application Number

210480

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2022-08-31

Regulatory Status

RX

2022
31 Aug
RX Application: 210480

Drug Name

LENALIDOMIDE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2022-08-31

210480 / 3

Active Ingredient

LENALIDOMIDE

Application Number

210480

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2022-08-31

Regulatory Status

RX

2022
31 Aug
RX Application: 210480

Drug Name

LENALIDOMIDE

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2022-08-31

210480 / 4

Active Ingredient

LENALIDOMIDE

Application Number

210480

Product Number

4

Dosage Form

-

Strength

25MG

Approval Date

2022-08-31

Regulatory Status

RX

2023
06 Mar
RX Application: 210480

Drug Name

LENALIDOMIDE

Product Number

5

Dosage Form

-

Strength

2.5MG

Approval Date

2023-03-06

210480 / 5

Active Ingredient

LENALIDOMIDE

Application Number

210480

Product Number

5

Dosage Form

-

Strength

2.5MG

Approval Date

2023-03-06

Regulatory Status

RX

2023
06 Mar
RX Application: 210480

Drug Name

LENALIDOMIDE

Product Number

6

Dosage Form

-

Strength

20MG

Approval Date

2023-03-06

210480 / 6

Active Ingredient

LENALIDOMIDE

Application Number

210480

Product Number

6

Dosage Form

-

Strength

20MG

Approval Date

2023-03-06

Regulatory Status

RX

2015
05 Jun
Discontinued Application: 202246

Drug Name

LEVONORGESTREL

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

2015-06-05

202246 / 1

Active Ingredient

LEVONORGESTREL

Application Number

202246

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

2015-06-05

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16908

Drug Name

LIDEX

Product Number

2

Dosage Form

-

Strength

0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

16908 / 2

Active Ingredient

FLUOCINONIDE

Application Number

16908

Product Number

2

Dosage Form

-

Strength

0.05% **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: 16909

Drug Name

LIDEX

Product Number

2

Dosage Form

-

Strength

0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

16909 / 2

Active Ingredient

FLUOCINONIDE

Application Number

16909

Product Number

2

Dosage Form

-

Strength

0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

1984
06 Apr
Discontinued Application: 18849

Drug Name

LIDEX

Product Number

1

Dosage Form

-

Strength

0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-04-06

18849 / 1

Active Ingredient

FLUOCINONIDE

Application Number

18849

Product Number

1

Dosage Form

-

Strength

0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1984-04-06

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 16908

Drug Name

LIDEX-E

Product Number

3

Dosage Form

-

Strength

0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

16908 / 3

Active Ingredient

FLUOCINONIDE

Application Number

16908

Product Number

3

Dosage Form

-

Strength

0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

1982-01-01

Regulatory Status

Discontinued

2017
22 Mar
Discontinued Application: 207809

Drug Name

MELPHALAN

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2017-03-22

207809 / 1

Active Ingredient

MELPHALAN

Application Number

207809

Product Number

1

Dosage Form

-

Strength

2MG

Approval Date

2017-03-22

Regulatory Status

Discontinued

2016
29 Feb
Discontinued Application: 204772

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2016-02-29

204772 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

204772

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2016-02-29

Regulatory Status

Discontinued

2016
29 Feb
Discontinued Application: 204772

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2016-02-29

204772 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

204772

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2016-02-29

Regulatory Status

Discontinued

2016
15 Sep
Discontinued Application: 206840

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2016-09-15

206840 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

206840

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2016-09-15

Regulatory Status

Discontinued

2016
15 Sep
Discontinued Application: 206840

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2016-09-15

206840 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

206840

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2016-09-15

Regulatory Status

Discontinued

2016
15 Sep
Discontinued Application: 206840

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2016-09-15

206840 / 3

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

206840

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2016-09-15

Regulatory Status

Discontinued

2018
30 Nov
Discontinued Application: 210818

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

18MG

Approval Date

2018-11-30

210818 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

210818

Product Number

1

Dosage Form

-

Strength

18MG

Approval Date

2018-11-30

Regulatory Status

Discontinued

2018
30 Nov
Discontinued Application: 210818

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

27MG

Approval Date

2018-11-30

210818 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

210818

Product Number

2

Dosage Form

-

Strength

27MG

Approval Date

2018-11-30

Regulatory Status

Discontinued

2018
30 Nov
Discontinued Application: 210818

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

36MG

Approval Date

2018-11-30

210818 / 3

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

210818

Product Number

3

Dosage Form

-

Strength

36MG

Approval Date

2018-11-30

Regulatory Status

Discontinued

2018
30 Nov
Discontinued Application: 210818

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

54MG

Approval Date

2018-11-30

210818 / 4

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

210818

Product Number

4

Dosage Form

-

Strength

54MG

Approval Date

2018-11-30

Regulatory Status

Discontinued

2015
11 Dec
Discontinued Application: 205055

Drug Name

NATEGLINIDE

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2015-12-11

205055 / 1

Active Ingredient

NATEGLINIDE

Application Number

205055

Product Number

1

Dosage Form

-

Strength

60MG

Approval Date

2015-12-11

Regulatory Status

Discontinued

2015
11 Dec
Discontinued Application: 205055

Drug Name

NATEGLINIDE

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

2015-12-11

205055 / 2

Active Ingredient

NATEGLINIDE

Application Number

205055

Product Number

2

Dosage Form

-

Strength

120MG

Approval Date

2015-12-11

Regulatory Status

Discontinued

2015
10 Jul
Discontinued Application: 204621

Drug Name

NEVIRAPINE

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2015-07-10

204621 / 1

Active Ingredient

NEVIRAPINE

Application Number

204621

Product Number

1

Dosage Form

-

Strength

400MG

Approval Date

2015-07-10

Regulatory Status

Discontinued

2015
09 Nov
Discontinued Application: 204621

Drug Name

NEVIRAPINE

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2015-11-09

204621 / 2

Active Ingredient

NEVIRAPINE

Application Number

204621

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2015-11-09

Regulatory Status

Discontinued

2022
20 Jul
Discontinued Application: 215002

Drug Name

NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)

Product Number

1

Dosage Form

-

Strength

75MG;25MG

Approval Date

2022-07-20

215002 / 1

Active Ingredient

NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE

Application Number

215002

Product Number

1

Dosage Form

-

Strength

75MG;25MG

Approval Date

2022-07-20

Regulatory Status

Discontinued

2004
31 Aug
Discontinued Application: 76830

Drug Name

OFLOXACIN

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2004-08-31

76830 / 1

Active Ingredient

OFLOXACIN

Application Number

76830

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2004-08-31

Regulatory Status

Discontinued

2009
11 Aug
Discontinued Application: 90395

Drug Name

OFLOXACIN

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2009-08-11

90395 / 1

Active Ingredient

OFLOXACIN

Application Number

90395

Product Number

1

Dosage Form

-

Strength

0.3%

Approval Date

2009-08-11

Regulatory Status

Discontinued

2017
31 Oct
RX Application: 208823

Drug Name

OSELTAMIVIR PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/ML

Approval Date

2017-10-31

208823 / 1

Active Ingredient

OSELTAMIVIR PHOSPHATE

Application Number

208823

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/ML

Approval Date

2017-10-31

Regulatory Status

RX

2012
26 Jul
RX Application: 202677

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2012-07-26

202677 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

202677

Product Number

1

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2012-07-26

Regulatory Status

RX

2012
26 Jul
RX Application: 202677

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;10MG

Approval Date

2012-07-26

202677 / 2

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

202677

Product Number

2

Dosage Form

-

Strength

325MG;10MG

Approval Date

2012-07-26

Regulatory Status

RX

2016
08 Mar
RX Application: 202677

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

325MG;5MG

Approval Date

2016-03-08

202677 / 3

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

202677

Product Number

3

Dosage Form

-

Strength

325MG;5MG

Approval Date

2016-03-08

Regulatory Status

RX

2011
30 Dec
RX Application: 202116

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-12-30

202116 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

202116

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-12-30

Regulatory Status

RX

2011
30 Dec
RX Application: 202116

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2011-12-30

202116 / 2

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

202116

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2011-12-30

Regulatory Status

RX

2011
30 Dec
RX Application: 202116

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2011-12-30

202116 / 3

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

202116

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2011-12-30

Regulatory Status

RX

2021
13 Apr
Discontinued Application: 211593

Drug Name

PREGABALIN

Product Number

1

Dosage Form

-

Strength

82.5MG

Approval Date

2021-04-13

211593 / 1

Active Ingredient

PREGABALIN

Application Number

211593

Product Number

1

Dosage Form

-

Strength

82.5MG

Approval Date

2021-04-13

Regulatory Status

Discontinued

2021
13 Apr
Discontinued Application: 211593

Drug Name

PREGABALIN

Product Number

2

Dosage Form

-

Strength

165MG

Approval Date

2021-04-13

211593 / 2

Active Ingredient

PREGABALIN

Application Number

211593

Product Number

2

Dosage Form

-

Strength

165MG

Approval Date

2021-04-13

Regulatory Status

Discontinued

2021
13 Apr
Discontinued Application: 211593

Drug Name

PREGABALIN

Product Number

3

Dosage Form

-

Strength

330MG

Approval Date

2021-04-13

211593 / 3

Active Ingredient

PREGABALIN

Application Number

211593

Product Number

3

Dosage Form

-

Strength

330MG

Approval Date

2021-04-13

Regulatory Status

Discontinued

2021
06 Jul
Discontinued Application: 211687

Drug Name

PREGABALIN

Product Number

1

Dosage Form

-

Strength

82.5MG

Approval Date

2021-07-06

211687 / 1

Active Ingredient

PREGABALIN

Application Number

211687

Product Number

1

Dosage Form

-

Strength

82.5MG

Approval Date

2021-07-06

Regulatory Status

Discontinued

2021
06 Jul
Discontinued Application: 211687

Drug Name

PREGABALIN

Product Number

2

Dosage Form

-

Strength

165MG

Approval Date

2021-07-06

211687 / 2

Active Ingredient

PREGABALIN

Application Number

211687

Product Number

2

Dosage Form

-

Strength

165MG

Approval Date

2021-07-06

Regulatory Status

Discontinued

2021
06 Jul
Discontinued Application: 211687

Drug Name

PREGABALIN

Product Number

3

Dosage Form

-

Strength

330MG

Approval Date

2021-07-06

211687 / 3

Active Ingredient

PREGABALIN

Application Number

211687

Product Number

3

Dosage Form

-

Strength

330MG

Approval Date

2021-07-06

Regulatory Status

Discontinued

2014
03 Feb
Discontinued Application: 203924

Drug Name

PRIMAQUINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2014-02-03

203924 / 1

Active Ingredient

PRIMAQUINE PHOSPHATE

Application Number

203924

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2014-02-03

Regulatory Status

Discontinued

2015
26 Jun
RX Application: 204737

Drug Name

PYRIDOSTIGMINE BROMIDE

Product Number

1

Dosage Form

-

Strength

180MG

Approval Date

2015-06-26

204737 / 1

Active Ingredient

PYRIDOSTIGMINE BROMIDE

Application Number

204737

Product Number

1

Dosage Form

-

Strength

180MG

Approval Date

2015-06-26

Regulatory Status

RX

2021
27 Jul
Discontinued Application: 211271

Drug Name

PYRIMETHAMINE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2021-07-27

211271 / 1

Active Ingredient

PYRIMETHAMINE

Application Number

211271

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2021-07-27

Regulatory Status

Discontinued

2015
03 Sep
Discontinued Application: 204403

Drug Name

RIVASTIGMINE

Product Number

1

Dosage Form

-

Strength

4.6MG/24HR

Approval Date

2015-09-03

204403 / 1

Active Ingredient

RIVASTIGMINE

Application Number

204403

Product Number

1

Dosage Form

-

Strength

4.6MG/24HR

Approval Date

2015-09-03

Regulatory Status

Discontinued

2015
03 Sep
Discontinued Application: 204403

Drug Name

RIVASTIGMINE

Product Number

2

Dosage Form

-

Strength

9.5MG/24HR

Approval Date

2015-09-03

204403 / 2

Active Ingredient

RIVASTIGMINE

Application Number

204403

Product Number

2

Dosage Form

-

Strength

9.5MG/24HR

Approval Date

2015-09-03

Regulatory Status

Discontinued

2015
31 Aug
Discontinued Application: 204403

Drug Name

RIVASTIGMINE

Product Number

3

Dosage Form

-

Strength

13.3MG/24HR

Approval Date

2015-08-31

204403 / 3

Active Ingredient

RIVASTIGMINE

Application Number

204403

Product Number

3

Dosage Form

-

Strength

13.3MG/24HR

Approval Date

2015-08-31

Regulatory Status

Discontinued

2011
18 Nov
Discontinued Application: 90910

Drug Name

SODIUM PHENYLBUTYRATE

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2011-11-18

90910 / 1

Active Ingredient

SODIUM PHENYLBUTYRATE

Application Number

90910

Product Number

1

Dosage Form

-

Strength

500MG

Approval Date

2011-11-18

Regulatory Status

Discontinued

1982
23 Dec
Discontinued Application: 18751

Drug Name

SPECTAZOLE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-12-23

18751 / 1

Active Ingredient

ECONAZOLE NITRATE

Application Number

18751

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1982-12-23

Regulatory Status

Discontinued

1985
31 Oct
Discontinued Application: 18830

Drug Name

TAMBOCOR

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1985-10-31

18830 / 1

Active Ingredient

FLECAINIDE ACETATE

Application Number

18830

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1985-10-31

Regulatory Status

Discontinued

1985
31 Oct
Discontinued Application: 18830

Drug Name

TAMBOCOR

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1985-10-31

18830 / 2

Active Ingredient

FLECAINIDE ACETATE

Application Number

18830

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1985-10-31

Regulatory Status

Discontinued

1988
03 Jun
Discontinued Application: 18830

Drug Name

TAMBOCOR

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1988-06-03

18830 / 3

Active Ingredient

FLECAINIDE ACETATE

Application Number

18830

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1988-06-03

Regulatory Status

Discontinued

1988
23 Aug
Discontinued Application: 18830

Drug Name

TAMBOCOR

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1988-08-23

18830 / 4

Active Ingredient

FLECAINIDE ACETATE

Application Number

18830

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1988-08-23

Regulatory Status

Discontinued

2002
24 Oct
RX Application: 21116

Drug Name

THYRO-TABS

Product Number

1

Dosage Form

-

Strength

0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-10-24

21116 / 1

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21116

Product Number

1

Dosage Form

-

Strength

0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-10-24

Regulatory Status

RX

2002
24 Oct
RX Application: 21116

Drug Name

THYRO-TABS

Product Number

2

Dosage Form

-

Strength

0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-10-24

21116 / 2

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21116

Product Number

2

Dosage Form

-

Strength

0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-10-24

Regulatory Status

RX

2002
24 Oct
RX Application: 21116

Drug Name

THYRO-TABS

Product Number

3

Dosage Form

-

Strength

0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-10-24

21116 / 3

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21116

Product Number

3

Dosage Form

-

Strength

0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-10-24

Regulatory Status

RX

2002
24 Oct
RX Application: 21116

Drug Name

THYRO-TABS

Product Number

4

Dosage Form

-

Strength

0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-10-24

21116 / 4

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21116

Product Number

4

Dosage Form

-

Strength

0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-10-24

Regulatory Status

RX

2002
24 Oct
RX Application: 21116

Drug Name

THYRO-TABS

Product Number

5

Dosage Form

-

Strength

0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-10-24

21116 / 5

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21116

Product Number

5

Dosage Form

-

Strength

0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-10-24

Regulatory Status

RX

2002
24 Oct
RX Application: 21116

Drug Name

THYRO-TABS

Product Number

6

Dosage Form

-

Strength

0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-10-24

21116 / 6

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21116

Product Number

6

Dosage Form

-

Strength

0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-10-24

Regulatory Status

RX

2002
24 Oct
RX Application: 21116

Drug Name

THYRO-TABS

Product Number

7

Dosage Form

-

Strength

0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-10-24

21116 / 7

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21116

Product Number

7

Dosage Form

-

Strength

0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-10-24

Regulatory Status

RX

2002
24 Oct
RX Application: 21116

Drug Name

THYRO-TABS

Product Number

8

Dosage Form

-

Strength

0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-10-24

21116 / 8

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21116

Product Number

8

Dosage Form

-

Strength

0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-10-24

Regulatory Status

RX

2002
24 Oct
RX Application: 21116

Drug Name

THYRO-TABS

Product Number

9

Dosage Form

-

Strength

0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-10-24

21116 / 9

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21116

Product Number

9

Dosage Form

-

Strength

0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-10-24

Regulatory Status

RX

2002
24 Oct
RX Application: 21116

Drug Name

THYRO-TABS

Product Number

10

Dosage Form

-

Strength

0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-10-24

21116 / 10

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21116

Product Number

10

Dosage Form

-

Strength

0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-10-24

Regulatory Status

RX

2002
24 Oct
RX Application: 21116

Drug Name

THYRO-TABS

Product Number

11

Dosage Form

-

Strength

0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-10-24

21116 / 11

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21116

Product Number

11

Dosage Form

-

Strength

0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-10-24

Regulatory Status

RX

2004
07 Dec
RX Application: 21116

Drug Name

THYRO-TABS

Product Number

12

Dosage Form

-

Strength

0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2004-12-07

21116 / 12

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21116

Product Number

12

Dosage Form

-

Strength

0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2004-12-07

Regulatory Status

RX

2020
29 Jul
Discontinued Application: 207729

Drug Name

TOLCAPONE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2020-07-29

207729 / 1

Active Ingredient

TOLCAPONE

Application Number

207729

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2020-07-29

Regulatory Status

Discontinued

1985
24 May
Discontinued Application: 18716

Drug Name

TRANDATE

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1985-05-24

18716 / 1

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

18716

Product Number

1

Dosage Form

-

Strength

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

Approval Date

1985-05-24

Regulatory Status

Discontinued

1984
01 Aug
Discontinued Application: 18716

Drug Name

TRANDATE

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1984-08-01

18716 / 2

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

18716

Product Number

2

Dosage Form

-

Strength

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

Approval Date

1984-08-01

Regulatory Status

Discontinued

1984
01 Aug
Discontinued Application: 18716

Drug Name

TRANDATE

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1984-08-01

18716 / 3

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

18716

Product Number

3

Dosage Form

-

Strength

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

Approval Date

1984-08-01

Regulatory Status

Discontinued

1984
01 Aug
Discontinued Application: 18716

Drug Name

TRANDATE

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1984-08-01

18716 / 4

Active Ingredient

LABETALOL HYDROCHLORIDE

Application Number

18716

Product Number

4

Dosage Form

-

Strength

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

Approval Date

1984-08-01

Regulatory Status

Discontinued

1988
18 Apr
Discontinued Application: 71514

Drug Name

TRAZODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1988-04-18

71514 / 1

Active Ingredient

TRAZODONE HYDROCHLORIDE

Application Number

71514

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1988-04-18

Regulatory Status

Discontinued

1988
18 Apr
Discontinued Application: 71636

Drug Name

TRAZODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1988-04-18

71636 / 1

Active Ingredient

TRAZODONE HYDROCHLORIDE

Application Number

71636

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1988-04-18

Regulatory Status

Discontinued

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Drug Status Breakdown
133 total
  • RX
  • Discontinued
  • Unclassified
Official Source

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

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FDA Approved Drug Record Details Preview

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

Drug Name

ACETYLCYSTEINE

Application Number

203853

Product Number

1

Active Ingredient

ACETYLCYSTEINE

Dosage Form

-

Strength

20%

FDA Approved Drug Data

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