Product Details for ANDA 077880
METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
500MG
Marketing Status: Prescription
850MG
Marketing Status: Prescription
1GM
Marketing Status: Prescription
500MG
Marketing Status: Prescription
Active Ingredient: METFORMIN HYDROCHLORIDE
Proprietary Name: METFORMIN HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077880
Product Number: 001
Approval Date: Jun 5, 2006
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS NY LLC
Marketing Status: Prescription
Patent and Exclusivity Information
METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
Proprietary Name: METFORMIN HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077880
Product Number: 001
Approval Date: Jun 5, 2006
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS NY LLC
Marketing Status: Prescription
Patent and Exclusivity Information
850MG
Marketing Status: Prescription
Active Ingredient: METFORMIN HYDROCHLORIDE
Proprietary Name: METFORMIN HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 850MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077880
Product Number: 002
Approval Date: Jun 5, 2006
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS NY LLC
Marketing Status: Prescription
Patent and Exclusivity Information
METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
Proprietary Name: METFORMIN HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 850MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077880
Product Number: 002
Approval Date: Jun 5, 2006
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS NY LLC
Marketing Status: Prescription
Patent and Exclusivity Information
1GM
Marketing Status: Prescription
Active Ingredient: METFORMIN HYDROCHLORIDE
Proprietary Name: METFORMIN HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1GM
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077880
Product Number: 003
Approval Date: Jun 5, 2006
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS NY LLC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: METFORMIN HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1GM
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A077880
Product Number: 003
Approval Date: Jun 5, 2006
Applicant Holder Full Name: AMNEAL PHARMACEUTICALS NY LLC
Marketing Status: Prescription
Patent and Exclusivity Information