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metformin hydrochloride

FDA Drug Profile — METFORMIN HYDROCHLORIDE, Glumetza, Metformin Hydrochloride, Metformin hydrochloride, METFORMIN HYDROCHLORIDE EXTENDED RELEASE

Drug Details

Generic Name
metformin hydrochloride
Brand Names
METFORMIN HYDROCHLORIDE, Glumetza, Metformin Hydrochloride, Metformin hydrochloride, METFORMIN HYDROCHLORIDE EXTENDED RELEASE, METFORMIN HYDROCHLORIDE ER
Application Number
ANDA213320
Sponsor
Vistin Pharma AS
NDC Codes
45
Dosage Forms
POWDER, TABLET, TABLET, EXTENDED RELEASE, TABLET, FILM COATED, EXTENDED RELEASE, TABLET, FILM COATED, GRANULE
Routes
ORAL
Active Ingredients
METFORMIN HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Metformin Hydrochloride Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. Metformin is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. ( 1 )