Organon RX
FDA Approved Drugs

Organon 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.

RX
  • Total Records 30
  • Latest Approval Date May 13, 2011
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
54
View
Discontinued
24
View
RX
30
View
Company Overview

Company

Organon RX

Country

U.S.A

Email

Social Profiles

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Company Snapshot

Organon RX

30 Hudson Street, Jersey City, NJ 07302

U.S.A

www.organon.com/ View on Map
FDA Approved Drug Records ( 30 records )
1982
01 Jan
RX Application: 14602

Drug Name

CELESTONE SOLUSPAN

Product Number

1

Dosage Form

-

Strength

3MG/ML;EQ 3MG BASE/ML

Approval Date

1982-01-01

14602 / 1

Active Ingredient

BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE

Application Number

14602

Product Number

1

Dosage Form

-

Strength

3MG/ML;EQ 3MG BASE/ML

Approval Date

1982-01-01

Regulatory Status

RX

2001
21 Dec
RX Application: 21165

Drug Name

CLARINEX

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2001-12-21

21165 / 1

Active Ingredient

DESLORATADINE

Application Number

21165

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2001-12-21

Regulatory Status

RX

1995
14 Apr
RX Application: 20386

Drug Name

COZAAR

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1995-04-14

20386 / 1

Active Ingredient

LOSARTAN POTASSIUM

Application Number

20386

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

1995-04-14

Regulatory Status

RX

1995
14 Apr
RX Application: 20386

Drug Name

COZAAR

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1995-04-14

20386 / 2

Active Ingredient

LOSARTAN POTASSIUM

Application Number

20386

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

1995-04-14

Regulatory Status

RX

1998
13 Oct
RX Application: 20386

Drug Name

COZAAR

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

1998-10-13

20386 / 3

Active Ingredient

LOSARTAN POTASSIUM

Application Number

20386

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

1998-10-13

Regulatory Status

RX

1983
27 Jul
RX Application: 18741

Drug Name

DIPROLENE

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1983-07-27

18741 / 1

Active Ingredient

BETAMETHASONE DIPROPIONATE

Application Number

18741

Product Number

1

Dosage Form

-

Strength

EQ 0.05% BASE

Approval Date

1983-07-27

Regulatory Status

RX

2000
20 Oct
RX Application: 20560

Drug Name

FOSAMAX

Product Number

5

Dosage Form

-

Strength

EQ 70MG BASE

Approval Date

2000-10-20

20560 / 5

Active Ingredient

ALENDRONATE SODIUM

Application Number

20560

Product Number

5

Dosage Form

-

Strength

EQ 70MG BASE

Approval Date

2000-10-20

Regulatory Status

RX

1995
28 Apr
RX Application: 20387

Drug Name

HYZAAR

Product Number

1

Dosage Form

-

Strength

12.5MG;50MG

Approval Date

1995-04-28

20387 / 1

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

20387

Product Number

1

Dosage Form

-

Strength

12.5MG;50MG

Approval Date

1995-04-28

Regulatory Status

RX

1998
10 Nov
RX Application: 20387

Drug Name

HYZAAR

Product Number

2

Dosage Form

-

Strength

25MG;100MG

Approval Date

1998-11-10

20387 / 2

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

20387

Product Number

2

Dosage Form

-

Strength

25MG;100MG

Approval Date

1998-11-10

Regulatory Status

RX

2005
20 Oct
RX Application: 20387

Drug Name

HYZAAR

Product Number

3

Dosage Form

-

Strength

12.5MG;100MG

Approval Date

2005-10-20

20387 / 3

Active Ingredient

HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM

Application Number

20387

Product Number

3

Dosage Form

-

Strength

12.5MG;100MG

Approval Date

2005-10-20

Regulatory Status

RX

1998
29 Jun
RX Application: 20865

Drug Name

MAXALT-MLT

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1998-06-29

20865 / 2

Active Ingredient

RIZATRIPTAN BENZOATE

Application Number

20865

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1998-06-29

Regulatory Status

RX

2011
13 May
RX Application: 21529

Drug Name

NEXPLANON

Product Number

2

Dosage Form

-

Strength

68MG/IMPLANT

Approval Date

2011-05-13

21529 / 2

Active Ingredient

ETONOGESTREL

Application Number

21529

Product Number

2

Dosage Form

-

Strength

68MG/IMPLANT

Approval Date

2011-05-13

Regulatory Status

RX

1997
19 Dec
RX Application: 20788

Drug Name

PROPECIA

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1997-12-19

20788 / 1

Active Ingredient

FINASTERIDE

Application Number

20788

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

1997-12-19

Regulatory Status

RX

1992
19 Jun
RX Application: 20180

Drug Name

PROSCAR

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1992-06-19

20180 / 1

Active Ingredient

FINASTERIDE

Application Number

20180

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1992-06-19

Regulatory Status

RX

1996
14 Jun
RX Application: 20415

Drug Name

REMERON

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1996-06-14

20415 / 1

Active Ingredient

MIRTAZAPINE

Application Number

20415

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

1996-06-14

Regulatory Status

RX

1996
14 Jun
RX Application: 20415

Drug Name

REMERON

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

1996-06-14

20415 / 2

Active Ingredient

MIRTAZAPINE

Application Number

20415

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

1996-06-14

Regulatory Status

RX

1982
01 Jan
RX Application: 17555

Drug Name

SINEMET

Product Number

1

Dosage Form

-

Strength

10MG;100MG

Approval Date

1982-01-01

17555 / 1

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

17555

Product Number

1

Dosage Form

-

Strength

10MG;100MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 17555

Drug Name

SINEMET

Product Number

2

Dosage Form

-

Strength

25MG;250MG

Approval Date

1982-01-01

17555 / 2

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

17555

Product Number

2

Dosage Form

-

Strength

25MG;250MG

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 17555

Drug Name

SINEMET

Product Number

3

Dosage Form

-

Strength

25MG;100MG

Approval Date

1982-01-01

17555 / 3

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

17555

Product Number

3

Dosage Form

-

Strength

25MG;100MG

Approval Date

1982-01-01

Regulatory Status

RX

1998
20 Feb
RX Application: 20829

Drug Name

SINGULAIR

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1998-02-20

20829 / 2

Active Ingredient

MONTELUKAST SODIUM

Application Number

20829

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

1998-02-20

Regulatory Status

RX

1998
20 Feb
RX Application: 20830

Drug Name

SINGULAIR

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1998-02-20

20830 / 1

Active Ingredient

MONTELUKAST SODIUM

Application Number

20830

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

1998-02-20

Regulatory Status

RX

2004
23 Jul
RX Application: 21687

Drug Name

VYTORIN

Product Number

1

Dosage Form

-

Strength

10MG;10MG

Approval Date

2004-07-23

21687 / 1

Active Ingredient

EZETIMIBE; SIMVASTATIN

Application Number

21687

Product Number

1

Dosage Form

-

Strength

10MG;10MG

Approval Date

2004-07-23

Regulatory Status

RX

2004
23 Jul
RX Application: 21687

Drug Name

VYTORIN

Product Number

2

Dosage Form

-

Strength

10MG;20MG

Approval Date

2004-07-23

21687 / 2

Active Ingredient

EZETIMIBE; SIMVASTATIN

Application Number

21687

Product Number

2

Dosage Form

-

Strength

10MG;20MG

Approval Date

2004-07-23

Regulatory Status

RX

2004
23 Jul
RX Application: 21687

Drug Name

VYTORIN

Product Number

3

Dosage Form

-

Strength

10MG;40MG

Approval Date

2004-07-23

21687 / 3

Active Ingredient

EZETIMIBE; SIMVASTATIN

Application Number

21687

Product Number

3

Dosage Form

-

Strength

10MG;40MG

Approval Date

2004-07-23

Regulatory Status

RX

2004
23 Jul
RX Application: 21687

Drug Name

VYTORIN

Product Number

4

Dosage Form

-

Strength

10MG;80MG

Approval Date

2004-07-23

21687 / 4

Active Ingredient

EZETIMIBE; SIMVASTATIN

Application Number

21687

Product Number

4

Dosage Form

-

Strength

10MG;80MG

Approval Date

2004-07-23

Regulatory Status

RX

2002
25 Oct
RX Application: 21445

Drug Name

ZETIA

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2002-10-25

21445 / 1

Active Ingredient

EZETIMIBE

Application Number

21445

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2002-10-25

Regulatory Status

RX

1991
23 Dec
RX Application: 19766

Drug Name

ZOCOR

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1991-12-23

19766 / 1

Active Ingredient

SIMVASTATIN

Application Number

19766

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

1991-12-23

Regulatory Status

RX

1991
23 Dec
RX Application: 19766

Drug Name

ZOCOR

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1991-12-23

19766 / 2

Active Ingredient

SIMVASTATIN

Application Number

19766

Product Number

2

Dosage Form

-

Strength

10MG

Approval Date

1991-12-23

Regulatory Status

RX

1991
23 Dec
RX Application: 19766

Drug Name

ZOCOR

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

1991-12-23

19766 / 3

Active Ingredient

SIMVASTATIN

Application Number

19766

Product Number

3

Dosage Form

-

Strength

20MG

Approval Date

1991-12-23

Regulatory Status

RX

1991
23 Dec
RX Application: 19766

Drug Name

ZOCOR

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

1991-12-23

19766 / 4

Active Ingredient

SIMVASTATIN

Application Number

19766

Product Number

4

Dosage Form

-

Strength

40MG

Approval Date

1991-12-23

Regulatory Status

RX

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Drug Status Breakdown
30 total
  • RX
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

CELESTONE SOLUSPAN

Application Number

14602

Product Number

1

Active Ingredient

BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE

Dosage Form

-

Strength

3MG/ML;EQ 3MG BASE/ML

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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