Product Details for ANDA 078905
GLIPIZIDE AND METFORMIN HYDROCHLORIDE (GLIPIZIDE; METFORMIN HYDROCHLORIDE)
2.5MG;250MG
Marketing Status: Prescription
2.5MG;500MG
Marketing Status: Prescription
5MG;500MG
Marketing Status: Prescription
2.5MG;250MG
Marketing Status: Prescription
Active Ingredient: GLIPIZIDE; METFORMIN HYDROCHLORIDE
Proprietary Name: GLIPIZIDE AND METFORMIN HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG;250MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078905
Product Number: 001
Approval Date: Jan 31, 2011
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
GLIPIZIDE AND METFORMIN HYDROCHLORIDE (GLIPIZIDE; METFORMIN HYDROCHLORIDE)
Proprietary Name: GLIPIZIDE AND METFORMIN HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG;250MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078905
Product Number: 001
Approval Date: Jan 31, 2011
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
2.5MG;500MG
Marketing Status: Prescription
Active Ingredient: GLIPIZIDE; METFORMIN HYDROCHLORIDE
Proprietary Name: GLIPIZIDE AND METFORMIN HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG;500MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078905
Product Number: 002
Approval Date: Jan 31, 2011
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
GLIPIZIDE AND METFORMIN HYDROCHLORIDE (GLIPIZIDE; METFORMIN HYDROCHLORIDE)
Proprietary Name: GLIPIZIDE AND METFORMIN HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG;500MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078905
Product Number: 002
Approval Date: Jan 31, 2011
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
5MG;500MG
Marketing Status: Prescription
Active Ingredient: GLIPIZIDE; METFORMIN HYDROCHLORIDE
Proprietary Name: GLIPIZIDE AND METFORMIN HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG;500MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078905
Product Number: 003
Approval Date: Jan 31, 2011
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: GLIPIZIDE AND METFORMIN HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG;500MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A078905
Product Number: 003
Approval Date: Jan 31, 2011
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information