ANDA 213256, held by Ani Pharms. Levothyroxine Sodium.
As of Nov 15, 2026, ANDA 213256 (Levothyroxine Sodium), held by Ani Pharms, was first approved by FDA on Jan 6, 2021, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 6, 2021 | Original application | Approved |
| Levothyroxine Sodium0.088MG · capsule;oral | Levothyroxine Sodium | Discontinued |
| Levothyroxine Sodium0.1MG · capsule;oral | Levothyroxine Sodium | Discontinued |
| Levothyroxine Sodium0.125MG · capsule;oral | Levothyroxine Sodium | 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
