Elite Laboratories, Inc.
FDA Approved Drugs

Elite Laboratories, Inc.

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
  • Total Records 60
  • Latest Approval Date Nov 10, 2025
  • Data Source FDA
  • First Approval Date May 30, 1997
All
60
View
Discontinued
4
View
RX
56
View
Company Overview

Company

Elite Laboratories, Inc.

Country

U.S.A

Website

Visit Website

Email

 info@elitepharma.com

Social Profiles

Company Snapshot

Elite Laboratories, Inc.

165 Ludlow Avenue Northvale, New Jersey 07647, USA

U.S.A

elitepharma.com/  info@elitepharma.com View on Map
FDA Approved Drug Records ( 60 records )
2019
10 Sep
RX Application: 212418

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;15MG

Approval Date

2019-09-10

212418 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

212418

Product Number

1

Dosage Form

-

Strength

300MG;15MG

Approval Date

2019-09-10

Regulatory Status

RX

2019
10 Sep
RX Application: 212418

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

2

Dosage Form

-

Strength

300MG;30MG

Approval Date

2019-09-10

212418 / 2

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

212418

Product Number

2

Dosage Form

-

Strength

300MG;30MG

Approval Date

2019-09-10

Regulatory Status

RX

2019
10 Sep
RX Application: 212418

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

3

Dosage Form

-

Strength

300MG;60MG

Approval Date

2019-09-10

212418 / 3

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

212418

Product Number

3

Dosage Form

-

Strength

300MG;60MG

Approval Date

2019-09-10

Regulatory Status

RX

2005
24 Oct
RX Application: 76686

Drug Name

DANTROLENE SODIUM

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2005-10-24

76686 / 1

Active Ingredient

DANTROLENE SODIUM

Application Number

76686

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2005-10-24

Regulatory Status

RX

2005
24 Oct
RX Application: 76686

Drug Name

DANTROLENE SODIUM

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2005-10-24

76686 / 2

Active Ingredient

DANTROLENE SODIUM

Application Number

76686

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2005-10-24

Regulatory Status

RX

2005
24 Oct
RX Application: 76686

Drug Name

DANTROLENE SODIUM

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2005-10-24

76686 / 3

Active Ingredient

DANTROLENE SODIUM

Application Number

76686

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2005-10-24

Regulatory Status

RX

2018
07 Dec
RX Application: 211352

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

2018-12-07

211352 / 1

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

211352

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2018-12-07

Regulatory Status

RX

2018
07 Dec
RX Application: 211352

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

2018-12-07

211352 / 2

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

211352

Product Number

2

Dosage Form

-

Strength

1.875MG;1.875MG;1.875MG;1.875MG

Approval Date

2018-12-07

Regulatory Status

RX

2018
07 Dec
RX Application: 211352

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

2018-12-07

211352 / 3

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

211352

Product Number

3

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2018-12-07

Regulatory Status

RX

2018
07 Dec
RX Application: 211352

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

2018-12-07

211352 / 4

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

211352

Product Number

4

Dosage Form

-

Strength

3.125MG;3.125MG;3.125MG;3.125MG

Approval Date

2018-12-07

Regulatory Status

RX

2018
07 Dec
RX Application: 211352

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

2018-12-07

211352 / 5

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

211352

Product Number

5

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG

Approval Date

2018-12-07

Regulatory Status

RX

2018
07 Dec
RX Application: 211352

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

6

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2018-12-07

211352 / 6

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

211352

Product Number

6

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2018-12-07

Regulatory Status

RX

2018
07 Dec
RX Application: 211352

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

2018-12-07

211352 / 7

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

211352

Product Number

7

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2018-12-07

Regulatory Status

RX

2019
11 Dec
RX Application: 212037

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

2019-12-11

212037 / 1

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

212037

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2019-12-11

Regulatory Status

RX

2019
11 Dec
RX Application: 212037

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

2019-12-11

212037 / 2

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

212037

Product Number

2

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2019-12-11

Regulatory Status

RX

2019
11 Dec
RX Application: 212037

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

2019-12-11

212037 / 3

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

212037

Product Number

3

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG

Approval Date

2019-12-11

Regulatory Status

RX

2019
11 Dec
RX Application: 212037

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

4

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2019-12-11

212037 / 4

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

212037

Product Number

4

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2019-12-11

Regulatory Status

RX

2019
11 Dec
RX Application: 212037

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

2019-12-11

212037 / 5

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

212037

Product Number

5

Dosage Form

-

Strength

6.25MG;6.25MG;6.25MG;6.25MG

Approval Date

2019-12-11

Regulatory Status

RX

2019
11 Dec
RX Application: 212037

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

2019-12-11

212037 / 6

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

212037

Product Number

6

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2019-12-11

Regulatory Status

RX

2018
16 Nov
RX Application: 209924

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;2.5MG

Approval Date

2018-11-16

209924 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

209924

Product Number

1

Dosage Form

-

Strength

325MG;2.5MG

Approval Date

2018-11-16

Regulatory Status

RX

2018
16 Nov
RX Application: 209924

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;5MG

Approval Date

2018-11-16

209924 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

209924

Product Number

2

Dosage Form

-

Strength

325MG;5MG

Approval Date

2018-11-16

Regulatory Status

RX

2018
16 Nov
RX Application: 209924

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2018-11-16

209924 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

209924

Product Number

3

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2018-11-16

Regulatory Status

RX

2018
16 Nov
RX Application: 209924

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

4

Dosage Form

-

Strength

325MG;10MG

Approval Date

2018-11-16

209924 / 4

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

209924

Product Number

4

Dosage Form

-

Strength

325MG;10MG

Approval Date

2018-11-16

Regulatory Status

RX

2006
24 Apr
RX Application: 77169

Drug Name

ISRADIPINE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2006-04-24

77169 / 1

Active Ingredient

ISRADIPINE

Application Number

77169

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2006-04-24

Regulatory Status

RX

2006
24 Apr
RX Application: 77169

Drug Name

ISRADIPINE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2006-04-24

77169 / 2

Active Ingredient

ISRADIPINE

Application Number

77169

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2006-04-24

Regulatory Status

RX

2024
15 Nov
RX Application: 218604

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2024-11-15

218604 / 1

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

218604

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2024-11-15

Regulatory Status

RX

2024
15 Nov
RX Application: 218604

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2024-11-15

218604 / 2

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

218604

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2024-11-15

Regulatory Status

RX

2024
15 Nov
RX Application: 218604

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2024-11-15

218604 / 3

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

218604

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2024-11-15

Regulatory Status

RX

2024
15 Nov
RX Application: 218604

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2024-11-15

218604 / 4

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

218604

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2024-11-15

Regulatory Status

RX

2024
15 Nov
RX Application: 218604

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2024-11-15

218604 / 5

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

218604

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2024-11-15

Regulatory Status

RX

2024
15 Nov
RX Application: 218604

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2024-11-15

218604 / 6

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

218604

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2024-11-15

Regulatory Status

RX

2024
15 Nov
RX Application: 218604

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

7

Dosage Form

-

Strength

70MG

Approval Date

2024-11-15

218604 / 7

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

218604

Product Number

7

Dosage Form

-

Strength

70MG

Approval Date

2024-11-15

Regulatory Status

RX

2005
04 Aug
RX Application: 76868

Drug Name

LOXAPINE SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2005-08-04

76868 / 1

Active Ingredient

LOXAPINE SUCCINATE

Application Number

76868

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2005-08-04

Regulatory Status

RX

2005
04 Aug
RX Application: 76868

Drug Name

LOXAPINE SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2005-08-04

76868 / 2

Active Ingredient

LOXAPINE SUCCINATE

Application Number

76868

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2005-08-04

Regulatory Status

RX

2005
04 Aug
RX Application: 76868

Drug Name

LOXAPINE SUCCINATE

Product Number

3

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2005-08-04

76868 / 3

Active Ingredient

LOXAPINE SUCCINATE

Application Number

76868

Product Number

3

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2005-08-04

Regulatory Status

RX

2005
04 Aug
RX Application: 76868

Drug Name

LOXAPINE SUCCINATE

Product Number

4

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2005-08-04

76868 / 4

Active Ingredient

LOXAPINE SUCCINATE

Application Number

76868

Product Number

4

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2005-08-04

Regulatory Status

RX

2018
02 Aug
RX Application: 210484

Drug Name

METHADONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2018-08-02

210484 / 1

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

210484

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2018-08-02

Regulatory Status

RX

2018
02 Aug
RX Application: 210484

Drug Name

METHADONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2018-08-02

210484 / 2

Active Ingredient

METHADONE HYDROCHLORIDE

Application Number

210484

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2018-08-02

Regulatory Status

RX

2024
16 May
RX Application: 216453

Drug Name

METHOTREXATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2024-05-16

216453 / 1

Active Ingredient

METHOTREXATE SODIUM

Application Number

216453

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2024-05-16

Regulatory Status

RX

1999
26 May
RX Application: 75274

Drug Name

NALTREXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1999-05-26

75274 / 1

Active Ingredient

NALTREXONE HYDROCHLORIDE

Application Number

75274

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

1999-05-26

Regulatory Status

RX

2018
02 Jul
RX Application: 209385

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

2018-07-02

209385 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

209385

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

2018-07-02

Regulatory Status

RX

2018
02 Jul
RX Application: 209385

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2018-07-02

209385 / 2

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

209385

Product Number

2

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2018-07-02

Regulatory Status

RX

2018
02 Jul
RX Application: 209385

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

325MG;10MG

Approval Date

2018-07-02

209385 / 3

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

209385

Product Number

3

Dosage Form

-

Strength

325MG;10MG

Approval Date

2018-07-02

Regulatory Status

RX

2008
28 Jan
RX Application: 40762

Drug Name

PHENDIMETRAZINE TARTRATE

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

2008-01-28

40762 / 1

Active Ingredient

PHENDIMETRAZINE TARTRATE

Application Number

40762

Product Number

1

Dosage Form

-

Strength

35MG

Approval Date

2008-01-28

Regulatory Status

RX

1997
30 May
RX Application: 40190

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

37.5MG

Approval Date

1997-05-30

40190 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

40190

Product Number

1

Dosage Form

-

Strength

37.5MG

Approval Date

1997-05-30

Regulatory Status

RX

1997
18 Jun
Discontinued Application: 40227

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1997-06-18

40227 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

40227

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

1997-06-18

Regulatory Status

Discontinued

1997
19 Jun
Discontinued Application: 40228

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

37.5MG

Approval Date

1997-06-19

40228 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

40228

Product Number

1

Dosage Form

-

Strength

37.5MG

Approval Date

1997-06-19

Regulatory Status

Discontinued

2003
22 Jan
Discontinued Application: 40448

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2003-01-22

40448 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

40448

Product Number

1

Dosage Form

-

Strength

30MG

Approval Date

2003-01-22

Regulatory Status

Discontinued

2003
14 Jan
Discontinued Application: 40460

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2003-01-14

40460 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

40460

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2003-01-14

Regulatory Status

Discontinued

2011
31 Jan
RX Application: 200272

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

37.5MG

Approval Date

2011-01-31

200272 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

200272

Product Number

1

Dosage Form

-

Strength

37.5MG

Approval Date

2011-01-31

Regulatory Status

RX

2012
28 Sep
RX Application: 202248

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2012-09-28

202248 / 1

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

202248

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2012-09-28

Regulatory Status

RX

2012
28 Sep
RX Application: 202248

Drug Name

PHENTERMINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2012-09-28

202248 / 2

Active Ingredient

PHENTERMINE HYDROCHLORIDE

Application Number

202248

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2012-09-28

Regulatory Status

RX

2025
10 Nov
RX Application: 217862

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2025-11-10

217862 / 1

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

217862

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2025-11-10

Regulatory Status

RX

2025
10 Nov
RX Application: 217862

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2025-11-10

217862 / 2

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

217862

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE

Approval Date

2025-11-10

Regulatory Status

RX

2025
10 Nov
RX Application: 217862

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 6MG BASE

Approval Date

2025-11-10

217862 / 3

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

217862

Product Number

3

Dosage Form

-

Strength

EQ 6MG BASE

Approval Date

2025-11-10

Regulatory Status

RX

2025
10 Nov
RX Application: 217862

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2025-11-10

217862 / 4

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

217862

Product Number

4

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2025-11-10

Regulatory Status

RX

2025
10 Nov
RX Application: 217862

Drug Name

ROPINIROLE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

EQ 12MG BASE

Approval Date

2025-11-10

217862 / 5

Active Ingredient

ROPINIROLE HYDROCHLORIDE

Application Number

217862

Product Number

5

Dosage Form

-

Strength

EQ 12MG BASE

Approval Date

2025-11-10

Regulatory Status

RX

2006
02 Aug
RX Application: 77361

Drug Name

TRIMIPRAMINE MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2006-08-02

77361 / 1

Active Ingredient

TRIMIPRAMINE MALEATE

Application Number

77361

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2006-08-02

Regulatory Status

RX

2006
02 Aug
RX Application: 77361

Drug Name

TRIMIPRAMINE MALEATE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2006-08-02

77361 / 2

Active Ingredient

TRIMIPRAMINE MALEATE

Application Number

77361

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2006-08-02

Regulatory Status

RX

2006
02 Aug
RX Application: 77361

Drug Name

TRIMIPRAMINE MALEATE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2006-08-02

77361 / 3

Active Ingredient

TRIMIPRAMINE MALEATE

Application Number

77361

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2006-08-02

Regulatory Status

RX

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Drug Status Breakdown
60 total
  • RX
  • Discontinued
Official Source

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

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

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

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Application Number

212418

Product Number

1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Dosage Form

-

Strength

300MG;15MG

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

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Organized FDA drug records

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