Noven Pharmaceuticals
FDA Approved Drugs
Noven Pharmaceuticals
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 26
- Latest Approval Date Mar 22, 2022
- Data Source FDA
- First Approval Date Jan 01, 1982
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FDA Approved Drug Records ( 26 records )
Drug Name
COMBIPATCH
Product Number
1
Dosage Form
-
Strength
0.05MG/24HR;0.14MG/24HR
Approval Date
1998-08-07
Active Ingredient
ESTRADIOL; NORETHINDRONE ACETATE
Application Number
20870
Product Number
1
Dosage Form
-
Strength
0.05MG/24HR;0.14MG/24HR
Approval Date
1998-08-07
Regulatory Status
RX
Drug Name
COMBIPATCH
Product Number
2
Dosage Form
-
Strength
0.05MG/24HR;0.25MG/24HR
Approval Date
1998-08-07
Active Ingredient
ESTRADIOL; NORETHINDRONE ACETATE
Application Number
20870
Product Number
2
Dosage Form
-
Strength
0.05MG/24HR;0.25MG/24HR
Approval Date
1998-08-07
Regulatory Status
RX
Drug Name
DAYTRANA
Product Number
1
Dosage Form
-
Strength
10MG/9HR (1.1MG/HR)
Approval Date
2006-04-06
Active Ingredient
METHYLPHENIDATE
Application Number
21514
Product Number
1
Dosage Form
-
Strength
10MG/9HR (1.1MG/HR)
Approval Date
2006-04-06
Regulatory Status
RX
Drug Name
DAYTRANA
Product Number
2
Dosage Form
-
Strength
15MG/9HR (1.6MG/HR)
Approval Date
2006-04-06
Active Ingredient
METHYLPHENIDATE
Application Number
21514
Product Number
2
Dosage Form
-
Strength
15MG/9HR (1.6MG/HR)
Approval Date
2006-04-06
Regulatory Status
RX
Drug Name
DAYTRANA
Product Number
3
Dosage Form
-
Strength
20MG/9HR (2.2MG/HR)
Approval Date
2006-04-06
Active Ingredient
METHYLPHENIDATE
Application Number
21514
Product Number
3
Dosage Form
-
Strength
20MG/9HR (2.2MG/HR)
Approval Date
2006-04-06
Regulatory Status
RX
Drug Name
DAYTRANA
Product Number
4
Dosage Form
-
Strength
30MG/9HR (3.3MG/HR)
Approval Date
2006-04-06
Active Ingredient
METHYLPHENIDATE
Application Number
21514
Product Number
4
Dosage Form
-
Strength
30MG/9HR (3.3MG/HR)
Approval Date
2006-04-06
Regulatory Status
RX
Drug Name
DENTIPATCH
Product Number
1
Dosage Form
-
Strength
23MG/PATCH
Approval Date
1996-05-21
Active Ingredient
LIDOCAINE
Application Number
20575
Product Number
1
Dosage Form
-
Strength
23MG/PATCH
Approval Date
1996-05-21
Regulatory Status
Discontinued
Drug Name
DENTIPATCH
Product Number
2
Dosage Form
-
Strength
46.1MG/PATCH
Approval Date
1996-05-21
Active Ingredient
LIDOCAINE
Application Number
20575
Product Number
2
Dosage Form
-
Strength
46.1MG/PATCH
Approval Date
1996-05-21
Regulatory Status
Discontinued
Drug Name
ESKALITH
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
1982-01-01
Active Ingredient
LITHIUM CARBONATE
Application Number
16860
Product Number
1
Dosage Form
-
Strength
300MG
Approval Date
1982-01-01
Regulatory Status
Discontinued
Drug Name
FENTANYL-100
Product Number
4
Dosage Form
-
Strength
100MCG/HR
Approval Date
2009-10-16
Active Ingredient
FENTANYL
Application Number
77775
Product Number
4
Dosage Form
-
Strength
100MCG/HR
Approval Date
2009-10-16
Regulatory Status
Discontinued
Drug Name
FENTANYL-25
Product Number
1
Dosage Form
-
Strength
25MCG/HR
Approval Date
2009-10-16
Active Ingredient
FENTANYL
Application Number
77775
Product Number
1
Dosage Form
-
Strength
25MCG/HR
Approval Date
2009-10-16
Regulatory Status
Discontinued
Drug Name
FENTANYL-50
Product Number
2
Dosage Form
-
Strength
50MCG/HR
Approval Date
2009-10-16
Active Ingredient
FENTANYL
Application Number
77775
Product Number
2
Dosage Form
-
Strength
50MCG/HR
Approval Date
2009-10-16
Regulatory Status
Discontinued
Drug Name
FENTANYL-75
Product Number
3
Dosage Form
-
Strength
75MCG/HR
Approval Date
2009-10-16
Active Ingredient
FENTANYL
Application Number
77775
Product Number
3
Dosage Form
-
Strength
75MCG/HR
Approval Date
2009-10-16
Regulatory Status
Discontinued
Drug Name
LIDOCAINE
Product Number
1
Dosage Form
-
Strength
5%
Approval Date
2020-12-01
Active Ingredient
LIDOCAINE
Application Number
203265
Product Number
1
Dosage Form
-
Strength
5%
Approval Date
2020-12-01
Regulatory Status
Discontinued
Drug Name
MINIVELLE
Product Number
1
Dosage Form
-
Strength
0.0375MG/24HR
Approval Date
2012-10-29
Active Ingredient
ESTRADIOL
Application Number
203752
Product Number
1
Dosage Form
-
Strength
0.0375MG/24HR
Approval Date
2012-10-29
Regulatory Status
RX
Drug Name
MINIVELLE
Product Number
2
Dosage Form
-
Strength
0.075MG/24HR
Approval Date
2012-10-29
Active Ingredient
ESTRADIOL
Application Number
203752
Product Number
2
Dosage Form
-
Strength
0.075MG/24HR
Approval Date
2012-10-29
Regulatory Status
RX
Drug Name
MINIVELLE
Product Number
3
Dosage Form
-
Strength
0.05MG/24HR
Approval Date
2012-10-29
Active Ingredient
ESTRADIOL
Application Number
203752
Product Number
3
Dosage Form
-
Strength
0.05MG/24HR
Approval Date
2012-10-29
Regulatory Status
RX
Drug Name
MINIVELLE
Product Number
4
Dosage Form
-
Strength
0.1MG/24HR
Approval Date
2012-10-29
Active Ingredient
ESTRADIOL
Application Number
203752
Product Number
4
Dosage Form
-
Strength
0.1MG/24HR
Approval Date
2012-10-29
Regulatory Status
RX
Drug Name
MINIVELLE
Product Number
5
Dosage Form
-
Strength
0.025MG/24HR
Approval Date
2014-09-23
Active Ingredient
ESTRADIOL
Application Number
203752
Product Number
5
Dosage Form
-
Strength
0.025MG/24HR
Approval Date
2014-09-23
Regulatory Status
RX
Drug Name
NITROGLYCERIN
Product Number
1
Dosage Form
-
Strength
0.2MG/HR
Approval Date
-
Active Ingredient
NITROGLYCERIN
Application Number
40047
Product Number
1
Dosage Form
-
Strength
0.2MG/HR
Approval Date
-
Regulatory Status
Unclassified
Drug Name
NITROGLYCERIN
Product Number
1
Dosage Form
-
Strength
0.4MG/HR
Approval Date
-
Active Ingredient
NITROGLYCERIN
Application Number
40048
Product Number
1
Dosage Form
-
Strength
0.4MG/HR
Approval Date
-
Regulatory Status
Unclassified
Drug Name
NITROGLYCERIN
Product Number
1
Dosage Form
-
Strength
0.6MG/HR
Approval Date
-
Active Ingredient
NITROGLYCERIN
Application Number
40049
Product Number
1
Dosage Form
-
Strength
0.6MG/HR
Approval Date
-
Regulatory Status
Unclassified
Drug Name
XELSTRYM
Product Number
1
Dosage Form
-
Strength
4.5MG/9HR
Approval Date
2022-03-22
Active Ingredient
DEXTROAMPHETAMINE
Application Number
215401
Product Number
1
Dosage Form
-
Strength
4.5MG/9HR
Approval Date
2022-03-22
Regulatory Status
RX
Drug Name
XELSTRYM
Product Number
2
Dosage Form
-
Strength
9MG/9HR
Approval Date
2022-03-22
Active Ingredient
DEXTROAMPHETAMINE
Application Number
215401
Product Number
2
Dosage Form
-
Strength
9MG/9HR
Approval Date
2022-03-22
Regulatory Status
RX
Drug Name
XELSTRYM
Product Number
3
Dosage Form
-
Strength
13.5MG/9HR
Approval Date
2022-03-22
Active Ingredient
DEXTROAMPHETAMINE
Application Number
215401
Product Number
3
Dosage Form
-
Strength
13.5MG/9HR
Approval Date
2022-03-22
Regulatory Status
RX
Drug Name
XELSTRYM
Product Number
4
Dosage Form
-
Strength
18MG/9HR
Approval Date
2022-03-22
Active Ingredient
DEXTROAMPHETAMINE
Application Number
215401
Product Number
4
Dosage Form
-
Strength
18MG/9HR
Approval Date
2022-03-22
Regulatory Status
RX
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FDA Approved Drugs Database
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Drug Status Breakdown
26 total- RX
- Discontinued
- 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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Drug Name
COMBIPATCH
Application Number
20870
Product Number
1
Active Ingredient
ESTRADIOL; NORETHINDRONE ACETATE
Dosage Form
-
Strength
0.05MG/24HR;0.14MG/24HR
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