Application Nr Approved Date Route Status External Links
ANDA203755 None Oral None 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 (0 Total)

None

Active Ingredients ( 1 Total)

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

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