Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 077127

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NIFEDIPINE (NIFEDIPINE)
30MG
Marketing Status: Prescription

Active Ingredient: NIFEDIPINE
Proprietary Name: NIFEDIPINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A077127
Product Number: 001
Approval Date: Nov 21, 2005
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

NIFEDIPINE (NIFEDIPINE)
60MG
Marketing Status: Prescription

Active Ingredient: NIFEDIPINE
Proprietary Name: NIFEDIPINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 60MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A077127
Product Number: 002
Approval Date: Nov 21, 2005
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

NIFEDIPINE (NIFEDIPINE)
90MG
Marketing Status: Prescription

Active Ingredient: NIFEDIPINE
Proprietary Name: NIFEDIPINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 90MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A077127
Product Number: 003
Approval Date: Oct 3, 2007
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information