For type 2 diabetes mellitus. ANDA 211163, held by Macleods Pharms. Metformin Hydrochloride.
As of Nov 15, 2026, ANDA 211163 (Metformin Hydrochloride), held by Macleods Pharms, was first approved by FDA on Mar 13, 2024, with 0 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 13, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Metformin Hydrochloride1GM · tablet, extended release;oral | Metformin Hydrochloride | Discontinued |
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
