U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Orange Book Home

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Home | Back to Search Results

Product Details for ANDA 091664

Expand all

METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
500MG
Marketing Status: Prescription
Active Ingredient: METFORMIN HYDROCHLORIDE
Proprietary Name: METFORMIN HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 500MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB3
Application Number: A091664
Product Number: 001
Approval Date: Jul 19, 2013
Applicant Holder Full Name: LUPIN 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, EXTENDED RELEASE; ORAL
Strength: 1GM
Reference Listed Drug: No
Reference Standard: No
TE Code: AB3
Application Number: A091664
Product Number: 002
Approval Date: Jul 19, 2013
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
Back to Top