Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 205096

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METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
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: A205096
Product Number: 001
Approval Date: Jul 11, 2016
Applicant Holder Full Name: CSPC OUYI PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
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: A205096
Product Number: 002
Approval Date: Jul 11, 2016
Applicant Holder Full Name: CSPC OUYI PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
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: A205096
Product Number: 003
Approval Date: Jul 11, 2016
Applicant Holder Full Name: CSPC OUYI PHARMACEUTICAL CO LTD
Marketing Status:  Prescription
Patent and Exclusivity Information