FDA.report

Metformin Hydrochloride

Product NDC
47335-305
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Metformin Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA202917
Marketing category
ANDA
Substance
METFORMIN HYDROCHLORIDE
Current FDA listing
Yes

Related Records

Packages

Package NDCDescriptionMarketing startMarketing endSampleStatus
47335-305-181000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-305-18) 2018-05-22NoHistorical
47335-305-8330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-305-83) 2018-05-22NoHistorical
47335-305-88100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-305-88) 2018-05-22NoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited2024-01-09Human Prescription Drug Label11