Product Details for NDA 020198
ADALAT CC (NIFEDIPINE)
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NIFEDIPINE
Proprietary Name: ADALAT CC
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Strength: 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020198
Product Number: 001
Approval Date: Apr 21, 1993
Applicant Holder Full Name: NORWICH PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
ADALAT CC (NIFEDIPINE)
Proprietary Name: ADALAT CC
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Strength: 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020198
Product Number: 001
Approval Date: Apr 21, 1993
Applicant Holder Full Name: NORWICH PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NIFEDIPINE
Proprietary Name: ADALAT CC
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N020198
Product Number: 002
Approval Date: Apr 21, 1993
Applicant Holder Full Name: NORWICH PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
ADALAT CC (NIFEDIPINE)
Proprietary Name: ADALAT CC
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 60MG **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: N020198
Product Number: 002
Approval Date: Apr 21, 1993
Applicant Holder Full Name: NORWICH PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
90MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: NIFEDIPINE
Proprietary Name: ADALAT CC
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 90MG **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: N020198
Product Number: 003
Approval Date: Apr 21, 1993
Applicant Holder Full Name: NORWICH PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: ADALAT CC
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 90MG **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: N020198
Product Number: 003
Approval Date: Apr 21, 1993
Applicant Holder Full Name: NORWICH PHARMACEUTICALS INC
Marketing Status: Discontinued
Patent and Exclusivity Information