Alvogen RX
FDA Approved Drugs

Alvogen RX

FDA Approved Drugs Database

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

RX
  • Total Records 58
  • Latest Approval Date Mar 06, 2023
  • Data Source FDA
  • First Approval Date Apr 28, 1983
All
133
View
Unclassified
6
View
Discontinued
69
View
RX
58
View
Company Overview

Company

Alvogen RX

Country

U.S.A

Website

Visit Website

Email

halldor.kristmannsson@alvogen.com

Social Profiles

Company Snapshot

Alvogen RX

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 ( 58 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
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

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

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

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

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

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

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

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Drug Status Breakdown
58 total
  • RX
Official Source

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

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

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

Drug Name

ACETYLCYSTEINE

Application Number

203853

Product Number

1

Active Ingredient

ACETYLCYSTEINE

Dosage Form

-

Strength

20%

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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