Application Nr Approved Date Route Status External Links
ANDA090692 2011-06-29 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Metformin Hydrochloride Extended-Release Tablets Are Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus.

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Ammonio Methacrylate Copolymer Type A AMMONIO METHACRYLATE COPOLYMER TYPE A Unresolved
2. Ammonio Methacrylate Copolymer Type B AMMONIO METHACRYLATE COPOLYMER TYPE B Unresolved
3. Hypromelloses HYPROMELLOSES Unresolved
4. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Metformin Hydrochloride METFORMIN HYDROCHLORIDE ZINC12859773

Comments