Application Nr Approved Date Route Status External Links
ANDA200690 2012-08-01 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 (13 Total)

Name Structure Kind Function Status
1. Ammonia AMMONIA Molecular
2. Cellulose Acetate CELLULOSE ACETATE Unresolved
3. Hypromelloses HYPROMELLOSES Unresolved
4. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
5. 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.
6. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
7. Povidones POVIDONES Unresolved
8. Ferric Oxide Red FERRIC OXIDE RED Molecular
9. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
10. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
11. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
12. Triacetin TRIACETIN Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
13. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

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