Product Details for ANDA 210012
NIFEDIPINE (NIFEDIPINE)
30MG
Marketing Status: Prescription
60MG
Marketing Status: Prescription
90MG
Marketing Status: Prescription
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: A210012
Product Number: 001
Approval Date: Dec 19, 2017
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
NIFEDIPINE (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: A210012
Product Number: 001
Approval Date: Dec 19, 2017
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: A210012
Product Number: 002
Approval Date: Dec 19, 2017
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
NIFEDIPINE (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: A210012
Product Number: 002
Approval Date: Dec 19, 2017
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: A210012
Product Number: 003
Approval Date: Dec 19, 2017
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
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: A210012
Product Number: 003
Approval Date: Dec 19, 2017
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information