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.
- Total Records 87
- Latest Approval Date Nov 04, 2025
- Data Source FDA
- First Approval Date Sep 01, 1982
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RHODES PHARMACEUTICALS LP
498 Washington StreetCoventry, RI 02816
U.S.A
www.rhodespharma.com:443/ View on MapFDA Approved Drug Records ( 87 records )
Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Number
1
Dosage Form
-
Strength
300MG;60MG
Approval Date
1988-02-10
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Application Number
89673
Product Number
1
Dosage Form
-
Strength
300MG;60MG
Approval Date
1988-02-10
Regulatory Status
Discontinued
Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Number
2
Dosage Form
-
Strength
300MG;15MG
Approval Date
1988-02-10
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Application Number
89673
Product Number
2
Dosage Form
-
Strength
300MG;15MG
Approval Date
1988-02-10
Regulatory Status
Discontinued
Drug Name
ACETAMINOPHEN AND CODEINE PHOSPHATE
Product Number
3
Dosage Form
-
Strength
300MG;30MG
Approval Date
1988-02-10
Active Ingredient
ACETAMINOPHEN; CODEINE PHOSPHATE
Application Number
89673
Product Number
3
Dosage Form
-
Strength
300MG;30MG
Approval Date
1988-02-10
Regulatory Status
Discontinued
Drug Name
AMPHETAMINE SULFATE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2021-09-07
Active Ingredient
AMPHETAMINE SULFATE
Application Number
213852
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2021-09-07
Regulatory Status
Discontinued
Drug Name
AMPHETAMINE SULFATE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2021-09-07
Active Ingredient
AMPHETAMINE SULFATE
Application Number
213852
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2021-09-07
Regulatory Status
Discontinued
Drug Name
APTENSIO XR
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2015-04-17
Active Ingredient
METHYLPHENIDATE HYDROCHLORIDE
Application Number
205831
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2015-04-17
Regulatory Status
RX
Drug Name
APTENSIO XR
Product Number
2
Dosage Form
-
Strength
15MG
Approval Date
2015-04-17
Active Ingredient
METHYLPHENIDATE HYDROCHLORIDE
Application Number
205831
Product Number
2
Dosage Form
-
Strength
15MG
Approval Date
2015-04-17
Regulatory Status
RX
Drug Name
APTENSIO XR
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
2015-04-17
Active Ingredient
METHYLPHENIDATE HYDROCHLORIDE
Application Number
205831
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
2015-04-17
Regulatory Status
RX
Drug Name
APTENSIO XR
Product Number
4
Dosage Form
-
Strength
30MG
Approval Date
2015-04-17
Active Ingredient
METHYLPHENIDATE HYDROCHLORIDE
Application Number
205831
Product Number
4
Dosage Form
-
Strength
30MG
Approval Date
2015-04-17
Regulatory Status
RX
Drug Name
APTENSIO XR
Product Number
5
Dosage Form
-
Strength
40MG
Approval Date
2015-04-17
Active Ingredient
METHYLPHENIDATE HYDROCHLORIDE
Application Number
205831
Product Number
5
Dosage Form
-
Strength
40MG
Approval Date
2015-04-17
Regulatory Status
RX
Drug Name
APTENSIO XR
Product Number
6
Dosage Form
-
Strength
50MG
Approval Date
2015-04-17
Active Ingredient
METHYLPHENIDATE HYDROCHLORIDE
Application Number
205831
Product Number
6
Dosage Form
-
Strength
50MG
Approval Date
2015-04-17
Regulatory Status
RX
Drug Name
APTENSIO XR
Product Number
7
Dosage Form
-
Strength
60MG
Approval Date
2015-04-17
Active Ingredient
METHYLPHENIDATE HYDROCHLORIDE
Application Number
205831
Product Number
7
Dosage Form
-
Strength
60MG
Approval Date
2015-04-17
Regulatory Status
RX
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
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
Drug Name
BUPRENORPHINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2017-03-27
Active Ingredient
BUPRENORPHINE HYDROCHLORIDE
Application Number
207276
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE
Approval Date
2017-03-27
Regulatory Status
RX
Drug Name
BUPRENORPHINE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 8MG BASE
Approval Date
2017-03-27
Active Ingredient
BUPRENORPHINE HYDROCHLORIDE
Application Number
207276
Product Number
2
Dosage Form
-
Strength
EQ 8MG BASE
Approval Date
2017-03-27
Regulatory Status
RX
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
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
Drug Name
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
EQ 8MG BASE;EQ 2MG BASE
Approval Date
2020-03-30
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
Drug Name
DEXMETHYLPHENIDATE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2017-11-20
Active Ingredient
DEXMETHYLPHENIDATE HYDROCHLORIDE
Application Number
208756
Product Number
1
Dosage Form
-
Strength
2.5MG
Approval Date
2017-11-20
Regulatory Status
Discontinued
Drug Name
DEXMETHYLPHENIDATE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2017-11-20
Active Ingredient
DEXMETHYLPHENIDATE HYDROCHLORIDE
Application Number
208756
Product Number
2
Dosage Form
-
Strength
5MG
Approval Date
2017-11-20
Regulatory Status
Discontinued
Drug Name
DEXMETHYLPHENIDATE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2017-11-20
Active Ingredient
DEXMETHYLPHENIDATE HYDROCHLORIDE
Application Number
208756
Product Number
3
Dosage Form
-
Strength
10MG
Approval Date
2017-11-20
Regulatory Status
Discontinued
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Drug Name
DILAUDID
Product Number
1
Dosage Form
-
Strength
5MG/5ML
Approval Date
1992-12-07
Active Ingredient
HYDROMORPHONE HYDROCHLORIDE
Application Number
19891
Product Number
1
Dosage Form
-
Strength
5MG/5ML
Approval Date
1992-12-07
Regulatory Status
RX
Drug Name
DILAUDID
Product Number
1
Dosage Form
-
Strength
8MG
Approval Date
1992-12-07
Active Ingredient
HYDROMORPHONE HYDROCHLORIDE
Application Number
19892
Product Number
1
Dosage Form
-
Strength
8MG
Approval Date
1992-12-07
Regulatory Status
RX
Drug Name
DILAUDID
Product Number
2
Dosage Form
-
Strength
4MG
Approval Date
2007-11-09
Active Ingredient
HYDROMORPHONE HYDROCHLORIDE
Application Number
19892
Product Number
2
Dosage Form
-
Strength
4MG
Approval Date
2007-11-09
Regulatory Status
RX
Drug Name
DILAUDID
Product Number
3
Dosage Form
-
Strength
2MG
Approval Date
2007-11-09
Active Ingredient
HYDROMORPHONE HYDROCHLORIDE
Application Number
19892
Product Number
3
Dosage Form
-
Strength
2MG
Approval Date
2007-11-09
Regulatory Status
RX
Drug Name
FENOFIBRATE
Product Number
1
Dosage Form
-
Strength
54MG
Approval Date
2005-05-13
Active Ingredient
FENOFIBRATE
Application Number
76433
Product Number
1
Dosage Form
-
Strength
54MG
Approval Date
2005-05-13
Regulatory Status
RX
Drug Name
FENOFIBRATE
Product Number
2
Dosage Form
-
Strength
160MG
Approval Date
2005-05-13
Active Ingredient
FENOFIBRATE
Application Number
76433
Product Number
2
Dosage Form
-
Strength
160MG
Approval Date
2005-05-13
Regulatory Status
RX
Drug Name
FENOFIBRATE (MICRONIZED)
Product Number
1
Dosage Form
-
Strength
67MG
Approval Date
2002-09-03
Active Ingredient
FENOFIBRATE
Application Number
75753
Product Number
1
Dosage Form
-
Strength
67MG
Approval Date
2002-09-03
Regulatory Status
RX
Drug Name
FENOFIBRATE (MICRONIZED)
Product Number
2
Dosage Form
-
Strength
134MG
Approval Date
2002-04-09
Active Ingredient
FENOFIBRATE
Application Number
75753
Product Number
2
Dosage Form
-
Strength
134MG
Approval Date
2002-04-09
Regulatory Status
RX
Drug Name
FENOFIBRATE (MICRONIZED)
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2002-04-09
Active Ingredient
FENOFIBRATE
Application Number
75753
Product Number
3
Dosage Form
-
Strength
200MG
Approval Date
2002-04-09
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;5MG
Approval Date
2016-04-12
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
202991
Product Number
1
Dosage Form
-
Strength
325MG;5MG
Approval Date
2016-04-12
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
325MG;7.5MG
Approval Date
2016-04-12
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
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
325MG;10MG
Approval Date
2016-04-12
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
202991
Product Number
3
Dosage Form
-
Strength
325MG;10MG
Approval Date
2016-04-12
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
300MG;5MG
Approval Date
2018-03-30
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
207808
Product Number
1
Dosage Form
-
Strength
300MG;5MG
Approval Date
2018-03-30
Regulatory Status
Discontinued
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
300MG;7.5MG
Approval Date
2018-03-30
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
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
300MG;10MG
Approval Date
2018-03-30
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
207808
Product Number
3
Dosage Form
-
Strength
300MG;10MG
Approval Date
2018-03-30
Regulatory Status
Discontinued
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2023-08-25
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
215330
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2023-08-25
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2023-08-25
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
215330
Product Number
2
Dosage Form
-
Strength
20MG
Approval Date
2023-08-25
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
3
Dosage Form
-
Strength
30MG
Approval Date
2023-08-25
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
215330
Product Number
3
Dosage Form
-
Strength
30MG
Approval Date
2023-08-25
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
4
Dosage Form
-
Strength
40MG
Approval Date
2023-08-25
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
215330
Product Number
4
Dosage Form
-
Strength
40MG
Approval Date
2023-08-25
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
5
Dosage Form
-
Strength
50MG
Approval Date
2023-08-25
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
215330
Product Number
5
Dosage Form
-
Strength
50MG
Approval Date
2023-08-25
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
6
Dosage Form
-
Strength
60MG
Approval Date
2023-08-25
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
215330
Product Number
6
Dosage Form
-
Strength
60MG
Approval Date
2023-08-25
Regulatory Status
RX
Drug Name
LISDEXAMFETAMINE DIMESYLATE
Product Number
7
Dosage Form
-
Strength
70MG
Approval Date
2023-08-25
Active Ingredient
LISDEXAMFETAMINE DIMESYLATE
Application Number
215330
Product Number
7
Dosage Form
-
Strength
70MG
Approval Date
2023-08-25
Regulatory Status
RX
Drug Name
MACITENTAN
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
-
Active Ingredient
MACITENTAN
Application Number
214112
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
MARAVIROC
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2025-11-04
Active Ingredient
MARAVIROC
Application Number
216143
Product Number
1
Dosage Form
-
Strength
150MG
Approval Date
2025-11-04
Regulatory Status
Discontinued
Drug Name
MARAVIROC
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2025-11-04
Active Ingredient
MARAVIROC
Application Number
216143
Product Number
2
Dosage Form
-
Strength
300MG
Approval Date
2025-11-04
Regulatory Status
Discontinued
Drug Name
METHYLPHENIDATE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
18MG
Approval Date
2022-05-31
Active Ingredient
METHYLPHENIDATE HYDROCHLORIDE
Application Number
214111
Product Number
1
Dosage Form
-
Strength
18MG
Approval Date
2022-05-31
Regulatory Status
Discontinued
Drug Name
METHYLPHENIDATE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
27MG
Approval Date
2022-05-31
Active Ingredient
METHYLPHENIDATE HYDROCHLORIDE
Application Number
214111
Product Number
2
Dosage Form
-
Strength
27MG
Approval Date
2022-05-31
Regulatory Status
Discontinued
Drug Name
METHYLPHENIDATE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
36MG
Approval Date
2022-05-31
Active Ingredient
METHYLPHENIDATE HYDROCHLORIDE
Application Number
214111
Product Number
3
Dosage Form
-
Strength
36MG
Approval Date
2022-05-31
Regulatory Status
Discontinued
Drug Name
METHYLPHENIDATE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
54MG
Approval Date
2022-05-31
Active Ingredient
METHYLPHENIDATE HYDROCHLORIDE
Application Number
214111
Product Number
4
Dosage Form
-
Strength
54MG
Approval Date
2022-05-31
Regulatory Status
Discontinued
Drug Name
MORPHINE SULFATE
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1998-07-02
Active Ingredient
MORPHINE SULFATE
Application Number
74769
Product Number
1
Dosage Form
-
Strength
100MG
Approval Date
1998-07-02
Regulatory Status
RX
Drug Name
MORPHINE SULFATE
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
1998-07-02
Active Ingredient
MORPHINE SULFATE
Application Number
74769
Product Number
2
Dosage Form
-
Strength
200MG
Approval Date
1998-07-02
Regulatory Status
RX
Drug Name
MORPHINE SULFATE
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
1998-07-07
Active Ingredient
MORPHINE SULFATE
Application Number
74862
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
1998-07-07
Regulatory Status
RX
Drug Name
MORPHINE SULFATE
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
1998-07-07
Active Ingredient
MORPHINE SULFATE
Application Number
74862
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
1998-07-07
Regulatory Status
RX
Drug Name
MORPHINE SULFATE
Product Number
3
Dosage Form
-
Strength
60MG
Approval Date
1998-07-07
Active Ingredient
MORPHINE SULFATE
Application Number
74862
Product Number
3
Dosage Form
-
Strength
60MG
Approval Date
1998-07-07
Regulatory Status
RX
Drug Name
MORPHINE SULFATE
Product Number
1
Dosage Form
-
Strength
10MG/5ML
Approval Date
2017-06-22
Active Ingredient
MORPHINE SULFATE
Application Number
206308
Product Number
1
Dosage Form
-
Strength
10MG/5ML
Approval Date
2017-06-22
Regulatory Status
Discontinued
Drug Name
MORPHINE SULFATE
Product Number
2
Dosage Form
-
Strength
100MG/5ML
Approval Date
2017-06-22
Active Ingredient
MORPHINE SULFATE
Application Number
206308
Product Number
2
Dosage Form
-
Strength
100MG/5ML
Approval Date
2017-06-22
Regulatory Status
Discontinued
Drug Name
MORPHINE SULFATE
Product Number
1
Dosage Form
-
Strength
20MG/5ML
Approval Date
2016-07-12
Active Ingredient
MORPHINE SULFATE
Application Number
206420
Product Number
1
Dosage Form
-
Strength
20MG/5ML
Approval Date
2016-07-12
Regulatory Status
Discontinued
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG;5MG
Approval Date
2014-08-28
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Application Number
201278
Product Number
1
Dosage Form
-
Strength
325MG;5MG
Approval Date
2014-08-28
Regulatory Status
RX
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
2
Dosage Form
-
Strength
325MG;7.5MG
Approval Date
2014-08-28
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
Drug Name
OXYCODONE AND ACETAMINOPHEN
Product Number
3
Dosage Form
-
Strength
325MG;10MG
Approval Date
2014-08-28
Active Ingredient
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Application Number
201278
Product Number
3
Dosage Form
-
Strength
325MG;10MG
Approval Date
2014-08-28
Regulatory Status
RX
Drug Name
OXYCODONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2011-03-09
Active Ingredient
OXYCODONE HYDROCHLORIDE
Application Number
91490
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2011-03-09
Regulatory Status
RX
Drug Name
OXYCODONE HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2011-03-09
Active Ingredient
OXYCODONE HYDROCHLORIDE
Application Number
91490
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
2011-03-09
Regulatory Status
RX
Drug Name
OXYCODONE HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
15MG
Approval Date
2011-03-09
Active Ingredient
OXYCODONE HYDROCHLORIDE
Application Number
91490
Product Number
3
Dosage Form
-
Strength
15MG
Approval Date
2011-03-09
Regulatory Status
RX
Drug Name
OXYCODONE HYDROCHLORIDE
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2011-03-09
Active Ingredient
OXYCODONE HYDROCHLORIDE
Application Number
91490
Product Number
4
Dosage Form
-
Strength
20MG
Approval Date
2011-03-09
Regulatory Status
RX
Drug Name
OXYCODONE HYDROCHLORIDE
Product Number
5
Dosage Form
-
Strength
30MG
Approval Date
2011-03-09
Active Ingredient
OXYCODONE HYDROCHLORIDE
Application Number
91490
Product Number
5
Dosage Form
-
Strength
30MG
Approval Date
2011-03-09
Regulatory Status
RX
Drug Name
OXYCODONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
100MG/5ML
Approval Date
2020-04-29
Active Ingredient
OXYCODONE HYDROCHLORIDE
Application Number
205853
Product Number
1
Dosage Form
-
Strength
100MG/5ML
Approval Date
2020-04-29
Regulatory Status
Discontinued
Drug Name
SCOPOLAMINE
Product Number
1
Dosage Form
-
Strength
1MG/72HR
Approval Date
2024-05-06
Active Ingredient
SCOPOLAMINE
Application Number
215329
Product Number
1
Dosage Form
-
Strength
1MG/72HR
Approval Date
2024-05-06
Regulatory Status
RX
Drug Name
TAPENTADOL HYDROCHLORIDE
Product Number
2
Dosage Form
-
Strength
75MG
Approval Date
-
Active Ingredient
TAPENTADOL HYDROCHLORIDE
Application Number
209369
Product Number
2
Dosage Form
-
Strength
75MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
TAPENTADOL HYDROCHLORIDE
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
-
Active Ingredient
TAPENTADOL HYDROCHLORIDE
Application Number
209369
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
-
Regulatory Status
Unclassified
Drug Name
THEOPHYLLINE
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
1996-04-15
Active Ingredient
THEOPHYLLINE
Application Number
40086
Product Number
1
Dosage Form
-
Strength
600MG
Approval Date
1996-04-15
Regulatory Status
Discontinued
Drug Name
THEOPHYLLINE
Product Number
2
Dosage Form
-
Strength
400MG
Approval Date
1982-09-01
Active Ingredient
THEOPHYLLINE
Application Number
40086
Product Number
2
Dosage Form
-
Strength
400MG
Approval Date
1982-09-01
Regulatory Status
RX
Drug Name
THEOPHYLLINE
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
2023-05-11
Active Ingredient
THEOPHYLLINE
Application Number
214113
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
2023-05-11
Regulatory Status
Discontinued
Drug Name
VARENICLINE TARTRATE
Product Number
1
Dosage Form
-
Strength
EQ 0.5MG BASE
Approval Date
2025-05-21
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
Drug Name
VARENICLINE TARTRATE
Product Number
2
Dosage Form
-
Strength
EQ 1MG BASE
Approval Date
2025-05-21
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.
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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
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Approved drug product information
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