Application Nr Approved Date Route Status External Links
ANDA203755 2016-08-01 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 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. Important Limitations Of Use Metformin Hydrochloride Extended-Release Tablets Should Not Be Used In Patients With Type 1 Diabetes Or For The Treatment Of Diabetic Ketoacidosis, As It Would Not Be Effective In These Settings. Metformin Hydrochloride Extended-Release Tablets Are A Biguanide Indicated As An Adjunct To Diet And Exercise To Improve Glycemic Control In Adults With Type 2 Diabetes Mellitus. (1) Important Limitations Of Use: Not For Treatment Of Type 1 Diabetes Or Diabetic Ketoacidosis. (1)

All Formulated Excipients (11 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
3. Lecithin LECITHIN 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. Povidones POVIDONES Unresolved
6. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
7. Polyvinyl Alcohol POLYVINYL ALCOHOL Unresolved
8. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
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

Active Ingredients ( 1 Total)

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

Comments