PHARM ASSOC RX
FDA Approved Drugs
PHARM ASSOC 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.
- Total Records 31
- Latest Approval Date Sep 12, 2023
- Data Source FDA
- First Approval Date Feb 10, 1982
Company Snapshot
FDA Approved Drug Records ( 31 records )
Drug Name
AMANTADINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
50MG/5ML
Approval Date
1995-07-17
Active Ingredient
AMANTADINE HYDROCHLORIDE
Application Number
74509
Product Number
1
Dosage Form
-
Strength
50MG/5ML
Approval Date
1995-07-17
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
2014-07-21
Active Ingredient
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Application Number
202940
Product Number
1
Dosage Form
-
Strength
2MG/5ML;10MG/5ML;30MG/5ML
Approval Date
2014-07-21
Regulatory Status
RX
Drug Name
CETIRIZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG/5ML
Approval Date
2008-06-18
Active Ingredient
CETIRIZINE HYDROCHLORIDE
Application Number
78412
Product Number
1
Dosage Form
-
Strength
5MG/5ML
Approval Date
2008-06-18
Regulatory Status
RX
Drug Name
CHLORHEXIDINE GLUCONATE
Product Number
1
Dosage Form
-
Strength
0.12%
Approval Date
1995-12-15
Active Ingredient
CHLORHEXIDINE GLUCONATE
Application Number
74522
Product Number
1
Dosage Form
-
Strength
0.12%
Approval Date
1995-12-15
Regulatory Status
RX
Drug Name
DIPHENHYDRAMINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
12.5MG/5ML
Approval Date
1982-02-10
Active Ingredient
DIPHENHYDRAMINE HYDROCHLORIDE
Application Number
87513
Product Number
1
Dosage Form
-
Strength
12.5MG/5ML
Approval Date
1982-02-10
Regulatory Status
RX
Drug Name
ETHOSUXIMIDE
Product Number
1
Dosage Form
-
Strength
250MG/5ML
Approval Date
2000-11-22
Active Ingredient
ETHOSUXIMIDE
Application Number
40253
Product Number
1
Dosage Form
-
Strength
250MG/5ML
Approval Date
2000-11-22
Regulatory Status
RX
Drug Name
FLUPHENAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
2.5MG/5ML
Approval Date
1996-08-21
Active Ingredient
FLUPHENAZINE HYDROCHLORIDE
Application Number
40146
Product Number
1
Dosage Form
-
Strength
2.5MG/5ML
Approval Date
1996-08-21
Regulatory Status
RX
Drug Name
FLUPHENAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG/ML
Approval Date
1996-09-16
Active Ingredient
FLUPHENAZINE HYDROCHLORIDE
Application Number
74725
Product Number
1
Dosage Form
-
Strength
5MG/ML
Approval Date
1996-09-16
Regulatory Status
RX
Drug Name
HALOPERIDOL
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML
Approval Date
1993-02-26
Active Ingredient
HALOPERIDOL LACTATE
Application Number
73037
Product Number
1
Dosage Form
-
Strength
EQ 2MG BASE/ML
Approval Date
1993-02-26
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG/15ML;10MG/15ML
Approval Date
2008-04-18
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
40834
Product Number
1
Dosage Form
-
Strength
325MG/15ML;10MG/15ML
Approval Date
2008-04-18
Regulatory Status
RX
Drug Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Number
1
Dosage Form
-
Strength
325MG/15ML;7.5MG/15ML
Approval Date
2013-05-10
Active Ingredient
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Application Number
40838
Product Number
1
Dosage Form
-
Strength
325MG/15ML;7.5MG/15ML
Approval Date
2013-05-10
Regulatory Status
RX
Drug Name
LACTULOSE
Product Number
1
Dosage Form
-
Strength
10GM/15ML
Approval Date
1996-07-30
Active Ingredient
LACTULOSE
Application Number
74623
Product Number
1
Dosage Form
-
Strength
10GM/15ML
Approval Date
1996-07-30
Regulatory Status
RX
Drug Name
LEVETIRACETAM
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2015-06-04
Active Ingredient
LEVETIRACETAM
Application Number
201157
Product Number
1
Dosage Form
-
Strength
100MG/ML
Approval Date
2015-06-04
Regulatory Status
RX
Drug Name
LORAZEPAM
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
2010-06-15
Active Ingredient
LORAZEPAM
Application Number
90260
Product Number
1
Dosage Form
-
Strength
2MG/ML
Approval Date
2010-06-15
Regulatory Status
RX
Drug Name
MORPHINE SULFATE
Product Number
1
Dosage Form
-
Strength
100MG/5ML
Approval Date
2016-11-14
Active Ingredient
MORPHINE SULFATE
Application Number
206573
Product Number
1
Dosage Form
-
Strength
100MG/5ML
Approval Date
2016-11-14
Regulatory Status
RX
Drug Name
MORPHINE SULFATE
Product Number
2
Dosage Form
-
Strength
10MG/5ML
Approval Date
2023-09-12
Active Ingredient
MORPHINE SULFATE
Application Number
206573
Product Number
2
Dosage Form
-
Strength
10MG/5ML
Approval Date
2023-09-12
Regulatory Status
RX
Drug Name
NORTRIPTYLINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/5ML
Approval Date
2000-08-23
Active Ingredient
NORTRIPTYLINE HYDROCHLORIDE
Application Number
75606
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/5ML
Approval Date
2000-08-23
Regulatory Status
RX
Drug Name
NYSTATIN
Product Number
1
Dosage Form
-
Strength
100,000 UNITS/ML
Approval Date
2016-01-07
Active Ingredient
NYSTATIN
Application Number
203621
Product Number
1
Dosage Form
-
Strength
100,000 UNITS/ML
Approval Date
2016-01-07
Regulatory Status
RX
Drug Name
ONDANSETRON HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/5ML
Approval Date
2007-06-25
Active Ingredient
ONDANSETRON HYDROCHLORIDE
Application Number
78127
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/5ML
Approval Date
2007-06-25
Regulatory Status
RX
Drug Name
OXYCODONE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
5MG/5ML
Approval Date
2019-02-01
Active Ingredient
OXYCODONE HYDROCHLORIDE
Application Number
206914
Product Number
1
Dosage Form
-
Strength
5MG/5ML
Approval Date
2019-02-01
Regulatory Status
RX
Drug Name
POTASSIUM CHLORIDE
Product Number
1
Dosage Form
-
Strength
20MEQ/15ML
Approval Date
2019-03-29
Active Ingredient
POTASSIUM CHLORIDE
Application Number
210766
Product Number
1
Dosage Form
-
Strength
20MEQ/15ML
Approval Date
2019-03-29
Regulatory Status
RX
Drug Name
POTASSIUM CHLORIDE
Product Number
2
Dosage Form
-
Strength
40MEQ/15ML
Approval Date
2019-03-29
Active Ingredient
POTASSIUM CHLORIDE
Application Number
210766
Product Number
2
Dosage Form
-
Strength
40MEQ/15ML
Approval Date
2019-03-29
Regulatory Status
RX
Drug Name
PREDNISOLONE
Product Number
1
Dosage Form
-
Strength
15MG/5ML
Approval Date
2005-08-25
Active Ingredient
PREDNISOLONE
Application Number
40571
Product Number
1
Dosage Form
-
Strength
15MG/5ML
Approval Date
2005-08-25
Regulatory Status
RX
Drug Name
PREDNISOLONE SODIUM PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 15MG BASE/5ML
Approval Date
2005-04-25
Active Ingredient
PREDNISOLONE SODIUM PHOSPHATE
Application Number
76913
Product Number
1
Dosage Form
-
Strength
EQ 15MG BASE/5ML
Approval Date
2005-04-25
Regulatory Status
RX
Drug Name
PREDNISOLONE SODIUM PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/5ML
Approval Date
2008-03-07
Active Ingredient
PREDNISOLONE SODIUM PHOSPHATE
Application Number
78465
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE/5ML
Approval Date
2008-03-07
Regulatory Status
RX
Drug Name
PREDNISOLONE SODIUM PHOSPHATE
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/5ML
Approval Date
2008-06-09
Active Ingredient
PREDNISOLONE SODIUM PHOSPHATE
Application Number
78988
Product Number
1
Dosage Form
-
Strength
EQ 20MG BASE/5ML
Approval Date
2008-06-09
Regulatory Status
RX
Drug Name
PROMETHAZINE HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
6.25MG/5ML
Approval Date
2006-04-26
Active Ingredient
PROMETHAZINE HYDROCHLORIDE
Application Number
40643
Product Number
1
Dosage Form
-
Strength
6.25MG/5ML
Approval Date
2006-04-26
Regulatory Status
RX
Drug Name
SULFATRIM PEDIATRIC
Product Number
1
Dosage Form
-
Strength
200MG/5ML;40MG/5ML
Approval Date
1983-01-07
Active Ingredient
SULFAMETHOXAZOLE; TRIMETHOPRIM
Application Number
18615
Product Number
1
Dosage Form
-
Strength
200MG/5ML;40MG/5ML
Approval Date
1983-01-07
Regulatory Status
RX
Drug Name
THEOPHYLLINE
Product Number
1
Dosage Form
-
Strength
80MG/15ML
Approval Date
2016-12-16
Active Ingredient
THEOPHYLLINE
Application Number
206344
Product Number
1
Dosage Form
-
Strength
80MG/15ML
Approval Date
2016-12-16
Regulatory Status
RX
Drug Name
TRIHEXYPHENIDYL HYDROCHLORIDE
Product Number
1
Dosage Form
-
Strength
2MG/5ML
Approval Date
1997-04-17
Active Ingredient
TRIHEXYPHENIDYL HYDROCHLORIDE
Application Number
40177
Product Number
1
Dosage Form
-
Strength
2MG/5ML
Approval Date
1997-04-17
Regulatory Status
RX
Drug Name
VALPROIC ACID
Product Number
1
Dosage Form
-
Strength
250MG/5ML
Approval Date
2000-12-15
Active Ingredient
VALPROIC ACID
Application Number
75379
Product Number
1
Dosage Form
-
Strength
250MG/5ML
Approval Date
2000-12-15
Regulatory Status
RX
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Drug Status Breakdown
31 total- RX
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
AMANTADINE HYDROCHLORIDE
Application Number
74509
Product Number
1
Active Ingredient
AMANTADINE HYDROCHLORIDE
Dosage Form
-
Strength
50MG/5ML
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