Metformin Hydrochloride

For type 2 diabetes mellitus. ANDA 209313, held by Granules. Metformin Hydrochloride.

As of Nov 15, 2026, ANDA 209313 (Metformin Hydrochloride), held by Granules, was first approved by FDA on Mar 16, 2018, with 3 approved supplements and 0 published complete response letters.

First approved: Mar 16, 2018
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Metformin hydrochloride extended-release 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Mar 16, 2018	Original application	Approved	None posted

Products

2 strengths and forms


Metformin Hydrochloride500MG · tablet, extended release;oral	Metformin Hydrochloride	Rx
Metformin Hydrochloride750MG · tablet, extended release;oral	Metformin Hydrochloride	Rx

All 4 submissions, including labeling and manufacturing supplements


Aug 11, 2026	Supplement 32Labeling · Standard review	Approved	None posted
Jul 27, 2026	Supplement 11Labeling · Standard review	Approved	None posted
Jan 14, 2019	Supplement 1Labeling · Standard review	Approved	None posted
Mar 16, 2018	Original application	Approved	None posted

Identifiers

Application: ANDA 209313
Drugs@FDA: Overview at FDA
Company: Granules India

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters