For type 2 diabetes mellitus. ANDA 212681, held by Prinston. Metformin Hydrochloride.
As of Nov 15, 2026, ANDA 212681 (Metformin Hydrochloride), held by Prinston, was first approved by FDA on Jun 9, 2022, 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 |
|---|---|---|---|
| Jun 9, 2022 | Original application | Approved | None posted |
| Metformin Hydrochloride500MG · tablet, extended release;oral | Metformin Hydrochloride | Rx |
| Metformin Hydrochloride1GM · tablet, extended release;oral | Metformin Hydrochloride | Rx |
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
