ANDA 213394, held by Utopic Pharms. Metformin Hydrochloride.
As of Nov 15, 2026, ANDA 213394 (Metformin Hydrochloride), held by Utopic Pharms, was first approved by FDA on Aug 3, 2021, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 3, 2021 | Original application | Approved | None posted |
| Metformin Hydrochloride500MG · tablet, extended release;oral | Metformin Hydrochloride | Discontinued |
| 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
