RHODES PHARMACEUTICALS LP
FDA Approved Drugs

RHODES PHARMACEUTICALS LP

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.

Discontinued RX Unclassified
  • Total Records 87
  • Latest Approval Date Nov 04, 2025
  • Data Source FDA
  • First Approval Date Sep 01, 1982
All
87
View
Unclassified
3
View
Discontinued
26
View
RX
58
View
Company Overview

Company

RHODES PHARMACEUTICALS LP

Country

U.S.A

Email

Social Profiles

Company Snapshot

RHODES PHARMACEUTICALS LP

498 Washington StreetCoventry, RI 02816

U.S.A

www.rhodespharma.com:443/ View on Map
FDA Approved Drug Records ( 87 records )
1988
10 Feb
Discontinued Application: 89673

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

1988-02-10

89673 / 1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

89673

Product Number

1

Dosage Form

-

Strength

300MG;60MG

Approval Date

1988-02-10

Regulatory Status

Discontinued

1988
10 Feb
Discontinued Application: 89673

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

2

Dosage Form

-

Strength

300MG;15MG

Approval Date

1988-02-10

89673 / 2

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

89673

Product Number

2

Dosage Form

-

Strength

300MG;15MG

Approval Date

1988-02-10

Regulatory Status

Discontinued

1988
10 Feb
Discontinued Application: 89673

Drug Name

ACETAMINOPHEN AND CODEINE PHOSPHATE

Product Number

3

Dosage Form

-

Strength

300MG;30MG

Approval Date

1988-02-10

89673 / 3

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Application Number

89673

Product Number

3

Dosage Form

-

Strength

300MG;30MG

Approval Date

1988-02-10

Regulatory Status

Discontinued

2021
07 Sep
Discontinued Application: 213852

Drug Name

AMPHETAMINE SULFATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2021-09-07

213852 / 1

Active Ingredient

AMPHETAMINE SULFATE

Application Number

213852

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2021-09-07

Regulatory Status

Discontinued

2021
07 Sep
Discontinued Application: 213852

Drug Name

AMPHETAMINE SULFATE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2021-09-07

213852 / 2

Active Ingredient

AMPHETAMINE SULFATE

Application Number

213852

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2021-09-07

Regulatory Status

Discontinued

2015
17 Apr
RX Application: 205831

Drug Name

APTENSIO XR

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2015-04-17

205831 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

205831

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2015-04-17

Regulatory Status

RX

2015
17 Apr
RX Application: 205831

Drug Name

APTENSIO XR

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2015-04-17

205831 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

205831

Product Number

2

Dosage Form

-

Strength

15MG

Approval Date

2015-04-17

Regulatory Status

RX

2015
17 Apr
RX Application: 205831

Drug Name

APTENSIO XR

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2015-04-17

205831 / 3

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

205831

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

2015-04-17

Regulatory Status

RX

2015
17 Apr
RX Application: 205831

Drug Name

APTENSIO XR

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2015-04-17

205831 / 4

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

205831

Product Number

4

Dosage Form

-

Strength

30MG

Approval Date

2015-04-17

Regulatory Status

RX

2015
17 Apr
RX Application: 205831

Drug Name

APTENSIO XR

Product Number

5

Dosage Form

-

Strength

40MG

Approval Date

2015-04-17

205831 / 5

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

205831

Product Number

5

Dosage Form

-

Strength

40MG

Approval Date

2015-04-17

Regulatory Status

RX

2015
17 Apr
RX Application: 205831

Drug Name

APTENSIO XR

Product Number

6

Dosage Form

-

Strength

50MG

Approval Date

2015-04-17

205831 / 6

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

205831

Product Number

6

Dosage Form

-

Strength

50MG

Approval Date

2015-04-17

Regulatory Status

RX

2015
17 Apr
RX Application: 205831

Drug Name

APTENSIO XR

Product Number

7

Dosage Form

-

Strength

60MG

Approval Date

2015-04-17

205831 / 7

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

205831

Product Number

7

Dosage Form

-

Strength

60MG

Approval Date

2015-04-17

Regulatory Status

RX

2020
05 Nov
Discontinued Application: 202955

Drug Name

BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

2MG/5ML;10MG/5ML;30MG/5ML

Approval Date

2020-11-05

202955 / 1

Active Ingredient

BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Application Number

202955

Product Number

1

Dosage Form

-

Strength

2MG/5ML;10MG/5ML;30MG/5ML

Approval Date

2020-11-05

Regulatory Status

Discontinued

2017
27 Mar
RX Application: 207276

Drug Name

BUPRENORPHINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2017-03-27

207276 / 1

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE

Application Number

207276

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2017-03-27

Regulatory Status

RX

2017
27 Mar
RX Application: 207276

Drug Name

BUPRENORPHINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2017-03-27

207276 / 2

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE

Application Number

207276

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE

Approval Date

2017-03-27

Regulatory Status

RX

2020
30 Mar
RX Application: 205601

Drug Name

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE;EQ 0.5MG BASE

Approval Date

2020-03-30

205601 / 1

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Application Number

205601

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE;EQ 0.5MG BASE

Approval Date

2020-03-30

Regulatory Status

RX

2020
30 Mar
RX Application: 205601

Drug Name

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE;EQ 2MG BASE

Approval Date

2020-03-30

205601 / 2

Active Ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Application Number

205601

Product Number

2

Dosage Form

-

Strength

EQ 8MG BASE;EQ 2MG BASE

Approval Date

2020-03-30

Regulatory Status

RX

2017
20 Nov
Discontinued Application: 208756

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2017-11-20

208756 / 1

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

208756

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2017-11-20

Regulatory Status

Discontinued

2017
20 Nov
Discontinued Application: 208756

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2017-11-20

208756 / 2

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

208756

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2017-11-20

Regulatory Status

Discontinued

2017
20 Nov
Discontinued Application: 208756

Drug Name

DEXMETHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2017-11-20

208756 / 3

Active Ingredient

DEXMETHYLPHENIDATE HYDROCHLORIDE

Application Number

208756

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2017-11-20

Regulatory Status

Discontinued

2019
17 May
RX Application: 210651

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

2019-05-17

210651 / 1

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

210651

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2019-05-17

Regulatory Status

RX

2019
17 May
RX Application: 210651

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

2019-05-17

210651 / 2

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

210651

Product Number

2

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2019-05-17

Regulatory Status

RX

2019
17 May
RX Application: 210651

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

2019-05-17

210651 / 3

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

210651

Product Number

3

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG

Approval Date

2019-05-17

Regulatory Status

RX

2019
17 May
RX Application: 210651

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

4

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2019-05-17

210651 / 4

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

210651

Product Number

4

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2019-05-17

Regulatory Status

RX

2019
17 May
RX Application: 210651

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

2019-05-17

210651 / 5

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

210651

Product Number

5

Dosage Form

-

Strength

6.25MG;6.25MG;6.25MG;6.25MG

Approval Date

2019-05-17

Regulatory Status

RX

2019
17 May
RX Application: 210651

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

2019-05-17

210651 / 6

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

210651

Product Number

6

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2019-05-17

Regulatory Status

RX

2021
13 Jan
RX Application: 213111

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

2021-01-13

213111 / 1

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

213111

Product Number

1

Dosage Form

-

Strength

1.25MG;1.25MG;1.25MG;1.25MG

Approval Date

2021-01-13

Regulatory Status

RX

2021
13 Jan
RX Application: 213111

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

2021-01-13

213111 / 2

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

213111

Product Number

2

Dosage Form

-

Strength

1.875MG;1.875MG;1.875MG;1.875MG

Approval Date

2021-01-13

Regulatory Status

RX

2021
13 Jan
RX Application: 213111

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

2021-01-13

213111 / 3

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

213111

Product Number

3

Dosage Form

-

Strength

2.5MG;2.5MG;2.5MG;2.5MG

Approval Date

2021-01-13

Regulatory Status

RX

2021
13 Jan
RX Application: 213111

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

2021-01-13

213111 / 4

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

213111

Product Number

4

Dosage Form

-

Strength

3.125MG;3.125MG;3.125MG;3.125MG

Approval Date

2021-01-13

Regulatory Status

RX

2021
13 Jan
RX Application: 213111

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

2021-01-13

213111 / 5

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

213111

Product Number

5

Dosage Form

-

Strength

3.75MG;3.75MG;3.75MG;3.75MG

Approval Date

2021-01-13

Regulatory Status

RX

2021
13 Jan
RX Application: 213111

Drug Name

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE

Product Number

6

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2021-01-13

213111 / 6

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

213111

Product Number

6

Dosage Form

-

Strength

5MG;5MG;5MG;5MG

Approval Date

2021-01-13

Regulatory Status

RX

2021
13 Jan
RX Application: 213111

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

2021-01-13

213111 / 7

Active Ingredient

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Application Number

213111

Product Number

7

Dosage Form

-

Strength

7.5MG;7.5MG;7.5MG;7.5MG

Approval Date

2021-01-13

Regulatory Status

RX

1992
07 Dec
RX Application: 19891

Drug Name

DILAUDID

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

1992-12-07

19891 / 1

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

19891

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

1992-12-07

Regulatory Status

RX

1992
07 Dec
RX Application: 19892

Drug Name

DILAUDID

Product Number

1

Dosage Form

-

Strength

8MG

Approval Date

1992-12-07

19892 / 1

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

19892

Product Number

1

Dosage Form

-

Strength

8MG

Approval Date

1992-12-07

Regulatory Status

RX

2007
09 Nov
RX Application: 19892

Drug Name

DILAUDID

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2007-11-09

19892 / 2

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

19892

Product Number

2

Dosage Form

-

Strength

4MG

Approval Date

2007-11-09

Regulatory Status

RX

2007
09 Nov
RX Application: 19892

Drug Name

DILAUDID

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2007-11-09

19892 / 3

Active Ingredient

HYDROMORPHONE HYDROCHLORIDE

Application Number

19892

Product Number

3

Dosage Form

-

Strength

2MG

Approval Date

2007-11-09

Regulatory Status

RX

2005
13 May
RX Application: 76433

Drug Name

FENOFIBRATE

Product Number

1

Dosage Form

-

Strength

54MG

Approval Date

2005-05-13

76433 / 1

Active Ingredient

FENOFIBRATE

Application Number

76433

Product Number

1

Dosage Form

-

Strength

54MG

Approval Date

2005-05-13

Regulatory Status

RX

2005
13 May
RX Application: 76433

Drug Name

FENOFIBRATE

Product Number

2

Dosage Form

-

Strength

160MG

Approval Date

2005-05-13

76433 / 2

Active Ingredient

FENOFIBRATE

Application Number

76433

Product Number

2

Dosage Form

-

Strength

160MG

Approval Date

2005-05-13

Regulatory Status

RX

2002
03 Sep
RX Application: 75753

Drug Name

FENOFIBRATE (MICRONIZED)

Product Number

1

Dosage Form

-

Strength

67MG

Approval Date

2002-09-03

75753 / 1

Active Ingredient

FENOFIBRATE

Application Number

75753

Product Number

1

Dosage Form

-

Strength

67MG

Approval Date

2002-09-03

Regulatory Status

RX

2002
09 Apr
RX Application: 75753

Drug Name

FENOFIBRATE (MICRONIZED)

Product Number

2

Dosage Form

-

Strength

134MG

Approval Date

2002-04-09

75753 / 2

Active Ingredient

FENOFIBRATE

Application Number

75753

Product Number

2

Dosage Form

-

Strength

134MG

Approval Date

2002-04-09

Regulatory Status

RX

2002
09 Apr
RX Application: 75753

Drug Name

FENOFIBRATE (MICRONIZED)

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2002-04-09

75753 / 3

Active Ingredient

FENOFIBRATE

Application Number

75753

Product Number

3

Dosage Form

-

Strength

200MG

Approval Date

2002-04-09

Regulatory Status

RX

2016
12 Apr
RX Application: 202991

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

2016-04-12

202991 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

202991

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

2016-04-12

Regulatory Status

RX

2016
12 Apr
RX Application: 202991

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2016-04-12

202991 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

202991

Product Number

2

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2016-04-12

Regulatory Status

RX

2016
12 Apr
RX Application: 202991

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

325MG;10MG

Approval Date

2016-04-12

202991 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

202991

Product Number

3

Dosage Form

-

Strength

325MG;10MG

Approval Date

2016-04-12

Regulatory Status

RX

2018
30 Mar
Discontinued Application: 207808

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

300MG;5MG

Approval Date

2018-03-30

207808 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

207808

Product Number

1

Dosage Form

-

Strength

300MG;5MG

Approval Date

2018-03-30

Regulatory Status

Discontinued

2018
30 Mar
Discontinued Application: 207808

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

300MG;7.5MG

Approval Date

2018-03-30

207808 / 2

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

207808

Product Number

2

Dosage Form

-

Strength

300MG;7.5MG

Approval Date

2018-03-30

Regulatory Status

Discontinued

2018
30 Mar
Discontinued Application: 207808

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

300MG;10MG

Approval Date

2018-03-30

207808 / 3

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

207808

Product Number

3

Dosage Form

-

Strength

300MG;10MG

Approval Date

2018-03-30

Regulatory Status

Discontinued

2023
25 Aug
RX Application: 215330

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2023-08-25

215330 / 1

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

215330

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 215330

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2023-08-25

215330 / 2

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

215330

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 215330

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2023-08-25

215330 / 3

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

215330

Product Number

3

Dosage Form

-

Strength

30MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 215330

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2023-08-25

215330 / 4

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

215330

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 215330

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2023-08-25

215330 / 5

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

215330

Product Number

5

Dosage Form

-

Strength

50MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 215330

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2023-08-25

215330 / 6

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

215330

Product Number

6

Dosage Form

-

Strength

60MG

Approval Date

2023-08-25

Regulatory Status

RX

2023
25 Aug
RX Application: 215330

Drug Name

LISDEXAMFETAMINE DIMESYLATE

Product Number

7

Dosage Form

-

Strength

70MG

Approval Date

2023-08-25

215330 / 7

Active Ingredient

LISDEXAMFETAMINE DIMESYLATE

Application Number

215330

Product Number

7

Dosage Form

-

Strength

70MG

Approval Date

2023-08-25

Regulatory Status

RX

-
Unclassified Application: 214112

Drug Name

MACITENTAN

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

-

214112 / 1

Active Ingredient

MACITENTAN

Application Number

214112

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

-

Regulatory Status

Unclassified

2025
04 Nov
Discontinued Application: 216143

Drug Name

MARAVIROC

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2025-11-04

216143 / 1

Active Ingredient

MARAVIROC

Application Number

216143

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2025-11-04

Regulatory Status

Discontinued

2025
04 Nov
Discontinued Application: 216143

Drug Name

MARAVIROC

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2025-11-04

216143 / 2

Active Ingredient

MARAVIROC

Application Number

216143

Product Number

2

Dosage Form

-

Strength

300MG

Approval Date

2025-11-04

Regulatory Status

Discontinued

2022
31 May
Discontinued Application: 214111

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

18MG

Approval Date

2022-05-31

214111 / 1

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

214111

Product Number

1

Dosage Form

-

Strength

18MG

Approval Date

2022-05-31

Regulatory Status

Discontinued

2022
31 May
Discontinued Application: 214111

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

27MG

Approval Date

2022-05-31

214111 / 2

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

214111

Product Number

2

Dosage Form

-

Strength

27MG

Approval Date

2022-05-31

Regulatory Status

Discontinued

2022
31 May
Discontinued Application: 214111

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

36MG

Approval Date

2022-05-31

214111 / 3

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

214111

Product Number

3

Dosage Form

-

Strength

36MG

Approval Date

2022-05-31

Regulatory Status

Discontinued

2022
31 May
Discontinued Application: 214111

Drug Name

METHYLPHENIDATE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

54MG

Approval Date

2022-05-31

214111 / 4

Active Ingredient

METHYLPHENIDATE HYDROCHLORIDE

Application Number

214111

Product Number

4

Dosage Form

-

Strength

54MG

Approval Date

2022-05-31

Regulatory Status

Discontinued

1998
02 Jul
RX Application: 74769

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1998-07-02

74769 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

74769

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

1998-07-02

Regulatory Status

RX

1998
02 Jul
RX Application: 74769

Drug Name

MORPHINE SULFATE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1998-07-02

74769 / 2

Active Ingredient

MORPHINE SULFATE

Application Number

74769

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

1998-07-02

Regulatory Status

RX

1998
07 Jul
RX Application: 74862

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1998-07-07

74862 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

74862

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1998-07-07

Regulatory Status

RX

1998
07 Jul
RX Application: 74862

Drug Name

MORPHINE SULFATE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

1998-07-07

74862 / 2

Active Ingredient

MORPHINE SULFATE

Application Number

74862

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

1998-07-07

Regulatory Status

RX

1998
07 Jul
RX Application: 74862

Drug Name

MORPHINE SULFATE

Product Number

3

Dosage Form

-

Strength

60MG

Approval Date

1998-07-07

74862 / 3

Active Ingredient

MORPHINE SULFATE

Application Number

74862

Product Number

3

Dosage Form

-

Strength

60MG

Approval Date

1998-07-07

Regulatory Status

RX

2017
22 Jun
Discontinued Application: 206308

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

10MG/5ML

Approval Date

2017-06-22

206308 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

206308

Product Number

1

Dosage Form

-

Strength

10MG/5ML

Approval Date

2017-06-22

Regulatory Status

Discontinued

2017
22 Jun
Discontinued Application: 206308

Drug Name

MORPHINE SULFATE

Product Number

2

Dosage Form

-

Strength

100MG/5ML

Approval Date

2017-06-22

206308 / 2

Active Ingredient

MORPHINE SULFATE

Application Number

206308

Product Number

2

Dosage Form

-

Strength

100MG/5ML

Approval Date

2017-06-22

Regulatory Status

Discontinued

2016
12 Jul
Discontinued Application: 206420

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

20MG/5ML

Approval Date

2016-07-12

206420 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

206420

Product Number

1

Dosage Form

-

Strength

20MG/5ML

Approval Date

2016-07-12

Regulatory Status

Discontinued

2014
28 Aug
RX Application: 201278

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

2014-08-28

201278 / 1

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

201278

Product Number

1

Dosage Form

-

Strength

325MG;5MG

Approval Date

2014-08-28

Regulatory Status

RX

2014
28 Aug
RX Application: 201278

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

2

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2014-08-28

201278 / 2

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

201278

Product Number

2

Dosage Form

-

Strength

325MG;7.5MG

Approval Date

2014-08-28

Regulatory Status

RX

2014
28 Aug
RX Application: 201278

Drug Name

OXYCODONE AND ACETAMINOPHEN

Product Number

3

Dosage Form

-

Strength

325MG;10MG

Approval Date

2014-08-28

201278 / 3

Active Ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Application Number

201278

Product Number

3

Dosage Form

-

Strength

325MG;10MG

Approval Date

2014-08-28

Regulatory Status

RX

2011
09 Mar
RX Application: 91490

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-03-09

91490 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

91490

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2011-03-09

Regulatory Status

RX

2011
09 Mar
RX Application: 91490

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-03-09

91490 / 2

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

91490

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

2011-03-09

Regulatory Status

RX

2011
09 Mar
RX Application: 91490

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2011-03-09

91490 / 3

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

91490

Product Number

3

Dosage Form

-

Strength

15MG

Approval Date

2011-03-09

Regulatory Status

RX

2011
09 Mar
RX Application: 91490

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2011-03-09

91490 / 4

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

91490

Product Number

4

Dosage Form

-

Strength

20MG

Approval Date

2011-03-09

Regulatory Status

RX

2011
09 Mar
RX Application: 91490

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

2011-03-09

91490 / 5

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

91490

Product Number

5

Dosage Form

-

Strength

30MG

Approval Date

2011-03-09

Regulatory Status

RX

2020
29 Apr
Discontinued Application: 205853

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2020-04-29

205853 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

205853

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2020-04-29

Regulatory Status

Discontinued

2024
06 May
RX Application: 215329

Drug Name

SCOPOLAMINE

Product Number

1

Dosage Form

-

Strength

1MG/72HR

Approval Date

2024-05-06

215329 / 1

Active Ingredient

SCOPOLAMINE

Application Number

215329

Product Number

1

Dosage Form

-

Strength

1MG/72HR

Approval Date

2024-05-06

Regulatory Status

RX

-
Unclassified Application: 209369

Drug Name

TAPENTADOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

75MG

Approval Date

-

209369 / 2

Active Ingredient

TAPENTADOL HYDROCHLORIDE

Application Number

209369

Product Number

2

Dosage Form

-

Strength

75MG

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 209369

Drug Name

TAPENTADOL HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

-

209369 / 3

Active Ingredient

TAPENTADOL HYDROCHLORIDE

Application Number

209369

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

-

Regulatory Status

Unclassified

1996
15 Apr
Discontinued Application: 40086

Drug Name

THEOPHYLLINE

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

1996-04-15

40086 / 1

Active Ingredient

THEOPHYLLINE

Application Number

40086

Product Number

1

Dosage Form

-

Strength

600MG

Approval Date

1996-04-15

Regulatory Status

Discontinued

1982
01 Sep
RX Application: 40086

Drug Name

THEOPHYLLINE

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

1982-09-01

40086 / 2

Active Ingredient

THEOPHYLLINE

Application Number

40086

Product Number

2

Dosage Form

-

Strength

400MG

Approval Date

1982-09-01

Regulatory Status

RX

2023
11 May
Discontinued Application: 214113

Drug Name

THEOPHYLLINE

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2023-05-11

214113 / 1

Active Ingredient

THEOPHYLLINE

Application Number

214113

Product Number

1

Dosage Form

-

Strength

300MG

Approval Date

2023-05-11

Regulatory Status

Discontinued

2025
21 May
Discontinued Application: 213268

Drug Name

VARENICLINE TARTRATE

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2025-05-21

213268 / 1

Active Ingredient

VARENICLINE TARTRATE

Application Number

213268

Product Number

1

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2025-05-21

Regulatory Status

Discontinued

2025
21 May
Discontinued Application: 213268

Drug Name

VARENICLINE TARTRATE

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2025-05-21

213268 / 2

Active Ingredient

VARENICLINE TARTRATE

Application Number

213268

Product Number

2

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2025-05-21

Regulatory Status

Discontinued

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Drug Status Breakdown
87 total
  • Discontinued
  • RX
  • Unclassified
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

89673

Product Number

1

Active Ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Dosage Form

-

Strength

300MG;60MG

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

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