PHARM ASSOC
FDA Approved Drugs

PHARM ASSOC

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 Unclassified
  • Total Records 68
  • Latest Approval Date Sep 12, 2023
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
68
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Unclassified
1
View
Discontinued
36
View
RX
31
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PHARM ASSOC

Country

U.S.A

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U.S.A

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FDA Approved Drug Records ( 68 records )
1995
17 Jul
RX Application: 74509

Drug Name

AMANTADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/5ML

Approval Date

1995-07-17

74509 / 1

Active Ingredient

AMANTADINE HYDROCHLORIDE

Application Number

74509

Product Number

1

Dosage Form

-

Strength

50MG/5ML

Approval Date

1995-07-17

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 87517

Drug Name

BROMPHENIRAMINE MALEATE

Product Number

1

Dosage Form

-

Strength

2MG/5ML

Approval Date

1982-01-01

87517 / 1

Active Ingredient

BROMPHENIRAMINE MALEATE

Application Number

87517

Product Number

1

Dosage Form

-

Strength

2MG/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2014
21 Jul
RX Application: 202940

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

202940 / 1

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

2008
18 Jun
RX Application: 78412

Drug Name

CETIRIZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2008-06-18

78412 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

78412

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2008-06-18

Regulatory Status

RX

2008
22 Apr
Discontinued Application: 90188

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE ALLERGY

Product Number

2

Dosage Form

-

Strength

5MG/5ML

Approval Date

2008-04-22

90188 / 2

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

90188

Product Number

2

Dosage Form

-

Strength

5MG/5ML

Approval Date

2008-04-22

Regulatory Status

Discontinued

2008
22 Apr
Discontinued Application: 90188

Drug Name

CHILDRENS CETIRIZINE HYDROCHLORIDE HIVES RELIEF

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2008-04-22

90188 / 1

Active Ingredient

CETIRIZINE HYDROCHLORIDE

Application Number

90188

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2008-04-22

Regulatory Status

Discontinued

1995
15 Dec
RX Application: 74522

Drug Name

CHLORHEXIDINE GLUCONATE

Product Number

1

Dosage Form

-

Strength

0.12%

Approval Date

1995-12-15

74522 / 1

Active Ingredient

CHLORHEXIDINE GLUCONATE

Application Number

74522

Product Number

1

Dosage Form

-

Strength

0.12%

Approval Date

1995-12-15

Regulatory Status

RX

1982
10 Feb
Discontinued Application: 87520

Drug Name

CHLORPHENIRAMINE MALEATE

Product Number

1

Dosage Form

-

Strength

2MG/5ML

Approval Date

1982-02-10

87520 / 1

Active Ingredient

CHLORPHENIRAMINE MALEATE

Application Number

87520

Product Number

1

Dosage Form

-

Strength

2MG/5ML

Approval Date

1982-02-10

Regulatory Status

Discontinued

1999
26 Jan
Discontinued Application: 40224

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1999-01-26

40224 / 1

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

40224

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1999-01-26

Regulatory Status

Discontinued

1999
30 Dec
Discontinued Application: 40231

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG/ML

Approval Date

1999-12-30

40231 / 1

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

40231

Product Number

1

Dosage Form

-

Strength

30MG/ML

Approval Date

1999-12-30

Regulatory Status

Discontinued

1997
27 Jan
Discontinued Application: 74553

Drug Name

CIMETIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE/5ML

Approval Date

1997-01-27

74553 / 1

Active Ingredient

CIMETIDINE HYDROCHLORIDE

Application Number

74553

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE/5ML

Approval Date

1997-01-27

Regulatory Status

Discontinued

2000
15 Mar
Discontinued Application: 75560

Drug Name

CIMETIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE/5ML

Approval Date

2000-03-15

75560 / 1

Active Ingredient

CIMETIDINE HYDROCHLORIDE

Application Number

75560

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE/5ML

Approval Date

2000-03-15

Regulatory Status

Discontinued

2005
15 Nov
Discontinued Application: 77601

Drug Name

CITALOPRAM HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/5ML

Approval Date

2005-11-15

77601 / 1

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

77601

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/5ML

Approval Date

2005-11-15

Regulatory Status

Discontinued

2005
05 Jan
Discontinued Application: 65167

Drug Name

CYCLOSPORINE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2005-01-05

65167 / 1

Active Ingredient

CYCLOSPORINE

Application Number

65167

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2005-01-05

Regulatory Status

Discontinued

2013
28 Mar
Discontinued Application: 91295

Drug Name

CYPROHEPTADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2MG/5ML

Approval Date

2013-03-28

91295 / 1

Active Ingredient

CYPROHEPTADINE HYDROCHLORIDE

Application Number

91295

Product Number

1

Dosage Form

-

Strength

2MG/5ML

Approval Date

2013-03-28

Regulatory Status

Discontinued

1982
10 Feb
RX Application: 87513

Drug Name

DIPHENHYDRAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

12.5MG/5ML

Approval Date

1982-02-10

87513 / 1

Active Ingredient

DIPHENHYDRAMINE HYDROCHLORIDE

Application Number

87513

Product Number

1

Dosage Form

-

Strength

12.5MG/5ML

Approval Date

1982-02-10

Regulatory Status

RX

2004
15 Jan
Discontinued Application: 75924

Drug Name

DOXEPIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2004-01-15

75924 / 1

Active Ingredient

DOXEPIN HYDROCHLORIDE

Application Number

75924

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2004-01-15

Regulatory Status

Discontinued

2000
22 Nov
RX Application: 40253

Drug Name

ETHOSUXIMIDE

Product Number

1

Dosage Form

-

Strength

250MG/5ML

Approval Date

2000-11-22

40253 / 1

Active Ingredient

ETHOSUXIMIDE

Application Number

40253

Product Number

1

Dosage Form

-

Strength

250MG/5ML

Approval Date

2000-11-22

Regulatory Status

RX

2002
30 Jan
Discontinued Application: 76015

Drug Name

FLUOXETINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/5ML

Approval Date

2002-01-30

76015 / 1

Active Ingredient

FLUOXETINE HYDROCHLORIDE

Application Number

76015

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/5ML

Approval Date

2002-01-30

Regulatory Status

Discontinued

1996
21 Aug
RX Application: 40146

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5MG/5ML

Approval Date

1996-08-21

40146 / 1

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

40146

Product Number

1

Dosage Form

-

Strength

2.5MG/5ML

Approval Date

1996-08-21

Regulatory Status

RX

1996
16 Sep
RX Application: 74725

Drug Name

FLUPHENAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1996-09-16

74725 / 1

Active Ingredient

FLUPHENAZINE HYDROCHLORIDE

Application Number

74725

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

1996-09-16

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 86823

Drug Name

H-CORT

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

86823 / 1

Active Ingredient

HYDROCORTISONE

Application Number

86823

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1982
01 Jan
Discontinued Application: 86824

Drug Name

H-CORT

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

86824 / 1

Active Ingredient

HYDROCORTISONE

Application Number

86824

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1982-01-01

Regulatory Status

Discontinued

1993
26 Feb
RX Application: 73037

Drug Name

HALOPERIDOL

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

1993-02-26

73037 / 1

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

1998
13 Mar
Discontinued Application: 40182

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

500MG/15ML;7.5MG/15ML

Approval Date

1998-03-13

40182 / 1

Active Ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Application Number

40182

Product Number

1

Dosage Form

-

Strength

500MG/15ML;7.5MG/15ML

Approval Date

1998-03-13

Regulatory Status

Discontinued

2008
18 Apr
RX Application: 40834

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG/15ML;10MG/15ML

Approval Date

2008-04-18

40834 / 1

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

2013
10 May
RX Application: 40838

Drug Name

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

325MG/15ML;7.5MG/15ML

Approval Date

2013-05-10

40838 / 1

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

1996
30 Jul
RX Application: 74623

Drug Name

LACTULOSE

Product Number

1

Dosage Form

-

Strength

10GM/15ML

Approval Date

1996-07-30

74623 / 1

Active Ingredient

LACTULOSE

Application Number

74623

Product Number

1

Dosage Form

-

Strength

10GM/15ML

Approval Date

1996-07-30

Regulatory Status

RX

2015
04 Jun
RX Application: 201157

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2015-06-04

201157 / 1

Active Ingredient

LEVETIRACETAM

Application Number

201157

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2015-06-04

Regulatory Status

RX

2004
05 Oct
Discontinued Application: 75565

Drug Name

LORATADINE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2004-10-05

75565 / 1

Active Ingredient

LORATADINE

Application Number

75565

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2004-10-05

Regulatory Status

Discontinued

-
Unclassified Application: 75565

Drug Name

LORATADINE

Product Number

2

Dosage Form

-

Strength

5MG/5ML

Approval Date

-

75565 / 2

Active Ingredient

LORATADINE

Application Number

75565

Product Number

2

Dosage Form

-

Strength

5MG/5ML

Approval Date

-

Regulatory Status

Unclassified

2010
15 Jun
RX Application: 90260

Drug Name

LORAZEPAM

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2010-06-15

90260 / 1

Active Ingredient

LORAZEPAM

Application Number

90260

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2010-06-15

Regulatory Status

RX

2005
09 Sep
Discontinued Application: 77115

Drug Name

MIDAZOLAM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2005-09-09

77115 / 1

Active Ingredient

MIDAZOLAM HYDROCHLORIDE

Application Number

77115

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2005-09-09

Regulatory Status

Discontinued

2016
14 Nov
RX Application: 206573

Drug Name

MORPHINE SULFATE

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2016-11-14

206573 / 1

Active Ingredient

MORPHINE SULFATE

Application Number

206573

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2016-11-14

Regulatory Status

RX

2023
12 Sep
RX Application: 206573

Drug Name

MORPHINE SULFATE

Product Number

2

Dosage Form

-

Strength

10MG/5ML

Approval Date

2023-09-12

206573 / 2

Active Ingredient

MORPHINE SULFATE

Application Number

206573

Product Number

2

Dosage Form

-

Strength

10MG/5ML

Approval Date

2023-09-12

Regulatory Status

RX

2000
23 Aug
RX Application: 75606

Drug Name

NORTRIPTYLINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/5ML

Approval Date

2000-08-23

75606 / 1

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

2016
07 Jan
RX Application: 203621

Drug Name

NYSTATIN

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/ML

Approval Date

2016-01-07

203621 / 1

Active Ingredient

NYSTATIN

Application Number

203621

Product Number

1

Dosage Form

-

Strength

100,000 UNITS/ML

Approval Date

2016-01-07

Regulatory Status

RX

2007
25 Jun
RX Application: 78127

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/5ML

Approval Date

2007-06-25

78127 / 1

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

1997
15 Oct
Discontinued Application: 74997

Drug Name

OXYBUTYNIN CHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

1997-10-15

74997 / 1

Active Ingredient

OXYBUTYNIN CHLORIDE

Application Number

74997

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

1997-10-15

Regulatory Status

Discontinued

1998
18 Dec
Discontinued Application: 75137

Drug Name

OXYBUTYNIN CHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

1998-12-18

75137 / 1

Active Ingredient

OXYBUTYNIN CHLORIDE

Application Number

75137

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

1998-12-18

Regulatory Status

Discontinued

2017
15 Aug
Discontinued Application: 206822

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2017-08-15

206822 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

206822

Product Number

1

Dosage Form

-

Strength

100MG/5ML

Approval Date

2017-08-15

Regulatory Status

Discontinued

2019
01 Feb
RX Application: 206914

Drug Name

OXYCODONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2019-02-01

206914 / 1

Active Ingredient

OXYCODONE HYDROCHLORIDE

Application Number

206914

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2019-02-01

Regulatory Status

RX

2001
25 May
Discontinued Application: 40360

Drug Name

PERPHENAZINE

Product Number

1

Dosage Form

-

Strength

16MG/5ML

Approval Date

2001-05-25

40360 / 1

Active Ingredient

PERPHENAZINE

Application Number

40360

Product Number

1

Dosage Form

-

Strength

16MG/5ML

Approval Date

2001-05-25

Regulatory Status

Discontinued

2019
29 Mar
RX Application: 210766

Drug Name

POTASSIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

20MEQ/15ML

Approval Date

2019-03-29

210766 / 1

Active Ingredient

POTASSIUM CHLORIDE

Application Number

210766

Product Number

1

Dosage Form

-

Strength

20MEQ/15ML

Approval Date

2019-03-29

Regulatory Status

RX

2019
29 Mar
RX Application: 210766

Drug Name

POTASSIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

40MEQ/15ML

Approval Date

2019-03-29

210766 / 2

Active Ingredient

POTASSIUM CHLORIDE

Application Number

210766

Product Number

2

Dosage Form

-

Strength

40MEQ/15ML

Approval Date

2019-03-29

Regulatory Status

RX

2003
05 Mar
Discontinued Application: 40399

Drug Name

PREDNISOLONE

Product Number

1

Dosage Form

-

Strength

15MG/5ML

Approval Date

2003-03-05

40399 / 1

Active Ingredient

PREDNISOLONE

Application Number

40399

Product Number

1

Dosage Form

-

Strength

15MG/5ML

Approval Date

2003-03-05

Regulatory Status

Discontinued

2005
25 Aug
Discontinued Application: 40570

Drug Name

PREDNISOLONE

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2005-08-25

40570 / 1

Active Ingredient

PREDNISOLONE

Application Number

40570

Product Number

1

Dosage Form

-

Strength

5MG/5ML

Approval Date

2005-08-25

Regulatory Status

Discontinued

2005
25 Aug
RX Application: 40571

Drug Name

PREDNISOLONE

Product Number

1

Dosage Form

-

Strength

15MG/5ML

Approval Date

2005-08-25

40571 / 1

Active Ingredient

PREDNISOLONE

Application Number

40571

Product Number

1

Dosage Form

-

Strength

15MG/5ML

Approval Date

2005-08-25

Regulatory Status

RX

2002
23 Dec
Discontinued Application: 76123

Drug Name

PREDNISOLONE SODIUM PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/5ML

Approval Date

2002-12-23

76123 / 1

Active Ingredient

PREDNISOLONE SODIUM PHOSPHATE

Application Number

76123

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/5ML

Approval Date

2002-12-23

Regulatory Status

Discontinued

2005
25 Apr
RX Application: 76913

Drug Name

PREDNISOLONE SODIUM PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE/5ML

Approval Date

2005-04-25

76913 / 1

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

2008
07 Mar
RX Application: 78465

Drug Name

PREDNISOLONE SODIUM PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/5ML

Approval Date

2008-03-07

78465 / 1

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

2008
09 Jun
RX Application: 78988

Drug Name

PREDNISOLONE SODIUM PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/5ML

Approval Date

2008-06-09

78988 / 1

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

2020
11 Mar
Discontinued Application: 204962

Drug Name

PREDNISOLONE SODIUM PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE/5ML

Approval Date

2020-03-11

204962 / 1

Active Ingredient

PREDNISOLONE SODIUM PHOSPHATE

Application Number

204962

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE/5ML

Approval Date

2020-03-11

Regulatory Status

Discontinued

2006
26 Apr
RX Application: 40643

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

6.25MG/5ML

Approval Date

2006-04-26

40643 / 1

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

40643

Product Number

1

Dosage Form

-

Strength

6.25MG/5ML

Approval Date

2006-04-26

Regulatory Status

RX

1982
01 Jan
Discontinued Application: 87518

Drug Name

PROMETHAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

6.25MG/5ML

Approval Date

1982-01-01

87518 / 1

Active Ingredient

PROMETHAZINE HYDROCHLORIDE

Application Number

87518

Product Number

1

Dosage Form

-

Strength

6.25MG/5ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

1988
22 Dec
Discontinued Application: 89647

Drug Name

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

Product Number

1

Dosage Form

-

Strength

10MG/5ML;6.25MG/5ML

Approval Date

1988-12-22

89647 / 1

Active Ingredient

CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

Application Number

89647

Product Number

1

Dosage Form

-

Strength

10MG/5ML;6.25MG/5ML

Approval Date

1988-12-22

Regulatory Status

Discontinued

2006
31 Jan
Discontinued Application: 40650

Drug Name

PROMETHAZINE WITH CODEINE

Product Number

1

Dosage Form

-

Strength

10MG/5ML;6.25MG/5ML

Approval Date

2006-01-31

40650 / 1

Active Ingredient

CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

Application Number

40650

Product Number

1

Dosage Form

-

Strength

10MG/5ML;6.25MG/5ML

Approval Date

2006-01-31

Regulatory Status

Discontinued

2007
21 Sep
Discontinued Application: 77405

Drug Name

RANITIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE/ML

Approval Date

2007-09-21

77405 / 1

Active Ingredient

RANITIDINE HYDROCHLORIDE

Application Number

77405

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE/ML

Approval Date

2007-09-21

Regulatory Status

Discontinued

2009
29 Jul
Discontinued Application: 77719

Drug Name

RISPERIDONE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2009-07-29

77719 / 1

Active Ingredient

RISPERIDONE

Application Number

77719

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2009-07-29

Regulatory Status

Discontinued

1983
07 Jan
Discontinued Application: 18615

Drug Name

SULFATRIM

Product Number

2

Dosage Form

-

Strength

200MG/5ML;40MG/5ML

Approval Date

1983-01-07

18615 / 2

Active Ingredient

SULFAMETHOXAZOLE; TRIMETHOPRIM

Application Number

18615

Product Number

2

Dosage Form

-

Strength

200MG/5ML;40MG/5ML

Approval Date

1983-01-07

Regulatory Status

Discontinued

1983
07 Jan
RX Application: 18615

Drug Name

SULFATRIM PEDIATRIC

Product Number

1

Dosage Form

-

Strength

200MG/5ML;40MG/5ML

Approval Date

1983-01-07

18615 / 1

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

1982
01 Jan
Discontinued Application: 86720

Drug Name

THEOPHYLLINE

Product Number

1

Dosage Form

-

Strength

80MG/15ML

Approval Date

1982-01-01

86720 / 1

Active Ingredient

THEOPHYLLINE

Application Number

86720

Product Number

1

Dosage Form

-

Strength

80MG/15ML

Approval Date

1982-01-01

Regulatory Status

Discontinued

2016
16 Dec
RX Application: 206344

Drug Name

THEOPHYLLINE

Product Number

1

Dosage Form

-

Strength

80MG/15ML

Approval Date

2016-12-16

206344 / 1

Active Ingredient

THEOPHYLLINE

Application Number

206344

Product Number

1

Dosage Form

-

Strength

80MG/15ML

Approval Date

2016-12-16

Regulatory Status

RX

1997
28 Aug
Discontinued Application: 40187

Drug Name

THIORIDAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

30MG/ML

Approval Date

1997-08-28

40187 / 1

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

40187

Product Number

1

Dosage Form

-

Strength

30MG/ML

Approval Date

1997-08-28

Regulatory Status

Discontinued

1998
29 May
Discontinued Application: 40213

Drug Name

THIORIDAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1998-05-29

40213 / 1

Active Ingredient

THIORIDAZINE HYDROCHLORIDE

Application Number

40213

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

1998-05-29

Regulatory Status

Discontinued

1997
17 Apr
RX Application: 40177

Drug Name

TRIHEXYPHENIDYL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2MG/5ML

Approval Date

1997-04-17

40177 / 1

Active Ingredient

TRIHEXYPHENIDYL HYDROCHLORIDE

Application Number

40177

Product Number

1

Dosage Form

-

Strength

2MG/5ML

Approval Date

1997-04-17

Regulatory Status

RX

1982
10 Feb
Discontinued Application: 87514

Drug Name

TRIPROLIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1.25MG/5ML

Approval Date

1982-02-10

87514 / 1

Active Ingredient

TRIPROLIDINE HYDROCHLORIDE

Application Number

87514

Product Number

1

Dosage Form

-

Strength

1.25MG/5ML

Approval Date

1982-02-10

Regulatory Status

Discontinued

2000
15 Dec
RX Application: 75379

Drug Name

VALPROIC ACID

Product Number

1

Dosage Form

-

Strength

250MG/5ML

Approval Date

2000-12-15

75379 / 1

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
68 total
  • RX
  • Discontinued
  • 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

AMANTADINE HYDROCHLORIDE

Application Number

74509

Product Number

1

Active Ingredient

AMANTADINE HYDROCHLORIDE

Dosage Form

-

Strength

50MG/5ML

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

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Searchable pharmaceutical data

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