Application Nr Approved Date Route Status External Links
ANDA075965 2002-01-25 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

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

All Formulated Excipients (3 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Hypromelloses HYPROMELLOSES Unresolved
3. 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.

Active Ingredients ( 1 Total)

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

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