Product Details for ANDA 203417
FELODIPINE (FELODIPINE)
2.5MG
Marketing Status: Prescription
5MG
Marketing Status: Prescription
10MG
Marketing Status: Prescription
2.5MG
Marketing Status: Prescription
Active Ingredient: FELODIPINE
Proprietary Name: FELODIPINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 2.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203417
Product Number: 001
Approval Date: Jan 17, 2013
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
FELODIPINE (FELODIPINE)
Proprietary Name: FELODIPINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 2.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203417
Product Number: 001
Approval Date: Jan 17, 2013
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
5MG
Marketing Status: Prescription
Active Ingredient: FELODIPINE
Proprietary Name: FELODIPINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203417
Product Number: 002
Approval Date: Jan 17, 2013
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
FELODIPINE (FELODIPINE)
Proprietary Name: FELODIPINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203417
Product Number: 002
Approval Date: Jan 17, 2013
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
10MG
Marketing Status: Prescription
Active Ingredient: FELODIPINE
Proprietary Name: FELODIPINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203417
Product Number: 003
Approval Date: Jan 17, 2013
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: FELODIPINE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A203417
Product Number: 003
Approval Date: Jan 17, 2013
Applicant Holder Full Name: AUROBINDO PHARMA LTD
Marketing Status: Prescription
Patent and Exclusivity Information