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Product Details for NDA 020356

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SULAR (NISOLDIPINE)
8.5MG
Marketing Status: Prescription
Active Ingredient: NISOLDIPINE
Proprietary Name: SULAR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 8.5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020356
Product Number: 008
Approval Date: Jan 2, 2008
Applicant Holder Full Name: COVIS PHARMA GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information
SULAR (NISOLDIPINE)
17MG
Marketing Status: Prescription
Active Ingredient: NISOLDIPINE
Proprietary Name: SULAR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 17MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020356
Product Number: 007
Approval Date: Jan 2, 2008
Applicant Holder Full Name: COVIS PHARMA GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information
SULAR (NISOLDIPINE)
34MG
Marketing Status: Prescription
Active Ingredient: NISOLDIPINE
Proprietary Name: SULAR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 34MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N020356
Product Number: 005
Approval Date: Jan 2, 2008
Applicant Holder Full Name: COVIS PHARMA GMBH
Marketing Status:  Prescription
Patent and Exclusivity Information
SULAR (NISOLDIPINE)
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NISOLDIPINE
Proprietary Name: SULAR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020356
Product Number: 001
Approval Date: Feb 2, 1995
Applicant Holder Full Name: COVIS PHARMA GMBH
Marketing Status:  Discontinued
Patent and Exclusivity Information
SULAR (NISOLDIPINE)
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NISOLDIPINE
Proprietary Name: SULAR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020356
Product Number: 002
Approval Date: Feb 2, 1995
Applicant Holder Full Name: COVIS PHARMA GMBH
Marketing Status:  Discontinued
Patent and Exclusivity Information
SULAR (NISOLDIPINE)
25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NISOLDIPINE
Proprietary Name: SULAR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020356
Product Number: 006
Approval Date: Jan 2, 2008
Applicant Holder Full Name: COVIS PHARMA GMBH
Marketing Status:  Discontinued
Patent and Exclusivity Information
SULAR (NISOLDIPINE)
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NISOLDIPINE
Proprietary Name: SULAR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020356
Product Number: 003
Approval Date: Feb 2, 1995
Applicant Holder Full Name: COVIS PHARMA GMBH
Marketing Status:  Discontinued
Patent and Exclusivity Information
SULAR (NISOLDIPINE)
40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NISOLDIPINE
Proprietary Name: SULAR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N020356
Product Number: 004
Approval Date: Feb 2, 1995
Applicant Holder Full Name: COVIS PHARMA GMBH
Marketing Status:  Discontinued
Patent and Exclusivity Information
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