Organon
FDA Approved Drugs
Organon
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 54
- Latest Approval Date May 03, 2013
- Data Source FDA
- First Approval Date Jan 01, 1982
Company Snapshot
FDA Approved Drug Records ( 54 records )
Drug Name
CELESTONE SOLUSPAN
Product Number
1
Dosage Form
-
Strength
3MG/ML;EQ 3MG BASE/ML
Approval Date
1982-01-01
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
Drug Name
CLARINEX
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2001-12-21
Active Ingredient
DESLORATADINE
Application Number
21165
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
2001-12-21
Regulatory Status
RX
Drug Name
CLARINEX
Product Number
1
Dosage Form
-
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2002-06-26
Active Ingredient
DESLORATADINE
Application Number
21312
Product Number
1
Dosage Form
-
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2002-06-26
Regulatory Status
Discontinued
Drug Name
CLARINEX
Product Number
2
Dosage Form
-
Strength
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2005-07-14
Active Ingredient
DESLORATADINE
Application Number
21312
Product Number
2
Dosage Form
-
Strength
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2005-07-14
Regulatory Status
Discontinued
Drug Name
CLARINEX D 24 HOUR
Product Number
1
Dosage Form
-
Strength
5MG;240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2005-03-03
Active Ingredient
DESLORATADINE; PSEUDOEPHEDRINE SULFATE
Application Number
21605
Product Number
1
Dosage Form
-
Strength
5MG;240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2005-03-03
Regulatory Status
Discontinued
Drug Name
COZAAR
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1995-04-14
Active Ingredient
LOSARTAN POTASSIUM
Application Number
20386
Product Number
1
Dosage Form
-
Strength
25MG
Approval Date
1995-04-14
Regulatory Status
RX
Drug Name
COZAAR
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
1995-04-14
Active Ingredient
LOSARTAN POTASSIUM
Application Number
20386
Product Number
2
Dosage Form
-
Strength
50MG
Approval Date
1995-04-14
Regulatory Status
RX
Drug Name
COZAAR
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
1998-10-13
Active Ingredient
LOSARTAN POTASSIUM
Application Number
20386
Product Number
3
Dosage Form
-
Strength
100MG
Approval Date
1998-10-13
Regulatory Status
RX
Drug Name
DIPROLENE
Product Number
1
Dosage Form
-
Strength
EQ 0.05% BASE
Approval Date
1983-07-27
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
Drug Name
DIPROLENE
Product Number
1
Dosage Form
-
Strength
EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1988-08-01
Active Ingredient
BETAMETHASONE DIPROPIONATE
Application Number
19716
Product Number
1
Dosage Form
-
Strength
EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1988-08-01
Regulatory Status
Discontinued
Drug Name
DIPROLENE AF
Product Number
1
Dosage Form
-
Strength
EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1987-04-27
Active Ingredient
BETAMETHASONE DIPROPIONATE
Application Number
19555
Product Number
1
Dosage Form
-
Strength
EQ 0.05% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1987-04-27
Regulatory Status
Discontinued
Drug Name
ELOCON
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
1987-04-30
Active Ingredient
MOMETASONE FUROATE
Application Number
19543
Product Number
1
Dosage Form
-
Strength
0.1%
Approval Date
1987-04-30
Regulatory Status
Discontinued
Drug Name
ELOCON
Product Number
1
Dosage Form
-
Strength
0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1987-05-06
Active Ingredient
MOMETASONE FUROATE
Application Number
19625
Product Number
1
Dosage Form
-
Strength
0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1987-05-06
Regulatory Status
Discontinued
Drug Name
ELOCON
Product Number
2
Dosage Form
-
Strength
0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2013-04-19
Active Ingredient
MOMETASONE FUROATE
Application Number
19625
Product Number
2
Dosage Form
-
Strength
0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2013-04-19
Regulatory Status
Discontinued
Drug Name
ELOCON
Product Number
1
Dosage Form
-
Strength
0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1989-03-30
Active Ingredient
MOMETASONE FUROATE
Application Number
19796
Product Number
1
Dosage Form
-
Strength
0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1989-03-30
Regulatory Status
Discontinued
Drug Name
FOSAMAX
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1995-09-29
Active Ingredient
ALENDRONATE SODIUM
Application Number
20560
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1995-09-29
Regulatory Status
Discontinued
Drug Name
FOSAMAX
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1995-09-29
Active Ingredient
ALENDRONATE SODIUM
Application Number
20560
Product Number
2
Dosage Form
-
Strength
EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1995-09-29
Regulatory Status
Discontinued
Drug Name
FOSAMAX
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-04-25
Active Ingredient
ALENDRONATE SODIUM
Application Number
20560
Product Number
3
Dosage Form
-
Strength
EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-04-25
Regulatory Status
Discontinued
Drug Name
FOSAMAX
Product Number
4
Dosage Form
-
Strength
EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2000-10-20
Active Ingredient
ALENDRONATE SODIUM
Application Number
20560
Product Number
4
Dosage Form
-
Strength
EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2000-10-20
Regulatory Status
Discontinued
Drug Name
FOSAMAX
Product Number
5
Dosage Form
-
Strength
EQ 70MG BASE
Approval Date
2000-10-20
Active Ingredient
ALENDRONATE SODIUM
Application Number
20560
Product Number
5
Dosage Form
-
Strength
EQ 70MG BASE
Approval Date
2000-10-20
Regulatory Status
RX
Drug Name
HYZAAR
Product Number
1
Dosage Form
-
Strength
12.5MG;50MG
Approval Date
1995-04-28
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
Drug Name
HYZAAR
Product Number
2
Dosage Form
-
Strength
25MG;100MG
Approval Date
1998-11-10
Active Ingredient
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
Application Number
20387
Product Number
2
Dosage Form
-
Strength
25MG;100MG
Approval Date
1998-11-10
Regulatory Status
RX
Drug Name
HYZAAR
Product Number
3
Dosage Form
-
Strength
12.5MG;100MG
Approval Date
2005-10-20
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
Drug Name
IMPLANON
Product Number
1
Dosage Form
-
Strength
68MG/IMPLANT
Approval Date
2006-07-17
Active Ingredient
ETONOGESTREL
Application Number
21529
Product Number
1
Dosage Form
-
Strength
68MG/IMPLANT
Approval Date
2006-07-17
Regulatory Status
Discontinued
Drug Name
LIPTRUZET
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2013-05-03
Active Ingredient
ATORVASTATIN CALCIUM; EZETIMIBE
Application Number
200153
Product Number
1
Dosage Form
-
Strength
EQ 10MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2013-05-03
Regulatory Status
Discontinued
Drug Name
LIPTRUZET
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2013-05-03
Active Ingredient
ATORVASTATIN CALCIUM; EZETIMIBE
Application Number
200153
Product Number
2
Dosage Form
-
Strength
EQ 20MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2013-05-03
Regulatory Status
Discontinued
Drug Name
LIPTRUZET
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2013-05-03
Active Ingredient
ATORVASTATIN CALCIUM; EZETIMIBE
Application Number
200153
Product Number
3
Dosage Form
-
Strength
EQ 40MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2013-05-03
Regulatory Status
Discontinued
Drug Name
LIPTRUZET
Product Number
4
Dosage Form
-
Strength
EQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2013-05-03
Active Ingredient
ATORVASTATIN CALCIUM; EZETIMIBE
Application Number
200153
Product Number
4
Dosage Form
-
Strength
EQ 80MG BASE;10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
2013-05-03
Regulatory Status
Discontinued
Drug Name
LOTRISONE
Product Number
1
Dosage Form
-
Strength
EQ 0.05% BASE;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1984-07-10
Active Ingredient
BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE
Application Number
18827
Product Number
1
Dosage Form
-
Strength
EQ 0.05% BASE;1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1984-07-10
Regulatory Status
Discontinued
Drug Name
MAXALT-MLT
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1998-06-29
Active Ingredient
RIZATRIPTAN BENZOATE
Application Number
20865
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1998-06-29
Regulatory Status
Discontinued
Drug Name
MAXALT-MLT
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1998-06-29
Active Ingredient
RIZATRIPTAN BENZOATE
Application Number
20865
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1998-06-29
Regulatory Status
RX
Drug Name
NEXPLANON
Product Number
2
Dosage Form
-
Strength
68MG/IMPLANT
Approval Date
2011-05-13
Active Ingredient
ETONOGESTREL
Application Number
21529
Product Number
2
Dosage Form
-
Strength
68MG/IMPLANT
Approval Date
2011-05-13
Regulatory Status
RX
Drug Name
PROPECIA
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
1997-12-19
Active Ingredient
FINASTERIDE
Application Number
20788
Product Number
1
Dosage Form
-
Strength
1MG
Approval Date
1997-12-19
Regulatory Status
RX
Drug Name
PROSCAR
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
1992-06-19
Active Ingredient
FINASTERIDE
Application Number
20180
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
1992-06-19
Regulatory Status
RX
Drug Name
REMERON
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
1996-06-14
Active Ingredient
MIRTAZAPINE
Application Number
20415
Product Number
1
Dosage Form
-
Strength
15MG
Approval Date
1996-06-14
Regulatory Status
RX
Drug Name
REMERON
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
1996-06-14
Active Ingredient
MIRTAZAPINE
Application Number
20415
Product Number
2
Dosage Form
-
Strength
30MG
Approval Date
1996-06-14
Regulatory Status
RX
Drug Name
REMERON
Product Number
3
Dosage Form
-
Strength
45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-03-17
Active Ingredient
MIRTAZAPINE
Application Number
20415
Product Number
3
Dosage Form
-
Strength
45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1997-03-17
Regulatory Status
Discontinued
Drug Name
SINEMET
Product Number
1
Dosage Form
-
Strength
10MG;100MG
Approval Date
1982-01-01
Active Ingredient
CARBIDOPA; LEVODOPA
Application Number
17555
Product Number
1
Dosage Form
-
Strength
10MG;100MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
SINEMET
Product Number
2
Dosage Form
-
Strength
25MG;250MG
Approval Date
1982-01-01
Active Ingredient
CARBIDOPA; LEVODOPA
Application Number
17555
Product Number
2
Dosage Form
-
Strength
25MG;250MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
SINEMET
Product Number
3
Dosage Form
-
Strength
25MG;100MG
Approval Date
1982-01-01
Active Ingredient
CARBIDOPA; LEVODOPA
Application Number
17555
Product Number
3
Dosage Form
-
Strength
25MG;100MG
Approval Date
1982-01-01
Regulatory Status
RX
Drug Name
SINGULAIR
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1998-02-20
Active Ingredient
MONTELUKAST SODIUM
Application Number
20829
Product Number
2
Dosage Form
-
Strength
EQ 10MG BASE
Approval Date
1998-02-20
Regulatory Status
RX
Drug Name
SINGULAIR
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
1998-02-20
Active Ingredient
MONTELUKAST SODIUM
Application Number
20830
Product Number
1
Dosage Form
-
Strength
EQ 5MG BASE
Approval Date
1998-02-20
Regulatory Status
RX
Drug Name
SINGULAIR
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2000-03-03
Active Ingredient
MONTELUKAST SODIUM
Application Number
20830
Product Number
2
Dosage Form
-
Strength
EQ 4MG BASE
Approval Date
2000-03-03
Regulatory Status
Discontinued
Drug Name
SINGULAIR
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/PACKET
Approval Date
2002-07-26
Active Ingredient
MONTELUKAST SODIUM
Application Number
21409
Product Number
1
Dosage Form
-
Strength
EQ 4MG BASE/PACKET
Approval Date
2002-07-26
Regulatory Status
Discontinued
Drug Name
VYTORIN
Product Number
1
Dosage Form
-
Strength
10MG;10MG
Approval Date
2004-07-23
Active Ingredient
EZETIMIBE; SIMVASTATIN
Application Number
21687
Product Number
1
Dosage Form
-
Strength
10MG;10MG
Approval Date
2004-07-23
Regulatory Status
RX
Drug Name
VYTORIN
Product Number
2
Dosage Form
-
Strength
10MG;20MG
Approval Date
2004-07-23
Active Ingredient
EZETIMIBE; SIMVASTATIN
Application Number
21687
Product Number
2
Dosage Form
-
Strength
10MG;20MG
Approval Date
2004-07-23
Regulatory Status
RX
Drug Name
VYTORIN
Product Number
3
Dosage Form
-
Strength
10MG;40MG
Approval Date
2004-07-23
Active Ingredient
EZETIMIBE; SIMVASTATIN
Application Number
21687
Product Number
3
Dosage Form
-
Strength
10MG;40MG
Approval Date
2004-07-23
Regulatory Status
RX
Drug Name
VYTORIN
Product Number
4
Dosage Form
-
Strength
10MG;80MG
Approval Date
2004-07-23
Active Ingredient
EZETIMIBE; SIMVASTATIN
Application Number
21687
Product Number
4
Dosage Form
-
Strength
10MG;80MG
Approval Date
2004-07-23
Regulatory Status
RX
Drug Name
ZETIA
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2002-10-25
Active Ingredient
EZETIMIBE
Application Number
21445
Product Number
1
Dosage Form
-
Strength
10MG
Approval Date
2002-10-25
Regulatory Status
RX
Drug Name
ZOCOR
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
1991-12-23
Active Ingredient
SIMVASTATIN
Application Number
19766
Product Number
1
Dosage Form
-
Strength
5MG
Approval Date
1991-12-23
Regulatory Status
RX
Drug Name
ZOCOR
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
1991-12-23
Active Ingredient
SIMVASTATIN
Application Number
19766
Product Number
2
Dosage Form
-
Strength
10MG
Approval Date
1991-12-23
Regulatory Status
RX
Drug Name
ZOCOR
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
1991-12-23
Active Ingredient
SIMVASTATIN
Application Number
19766
Product Number
3
Dosage Form
-
Strength
20MG
Approval Date
1991-12-23
Regulatory Status
RX
Drug Name
ZOCOR
Product Number
4
Dosage Form
-
Strength
40MG
Approval Date
1991-12-23
Active Ingredient
SIMVASTATIN
Application Number
19766
Product Number
4
Dosage Form
-
Strength
40MG
Approval Date
1991-12-23
Regulatory Status
RX
Drug Name
ZOCOR
Product Number
5
Dosage Form
-
Strength
80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1998-07-10
Active Ingredient
SIMVASTATIN
Application Number
19766
Product Number
5
Dosage Form
-
Strength
80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date
1998-07-10
Regulatory Status
Discontinued
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Drug Status Breakdown
54 total- RX
- Discontinued
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
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
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