ANDA 210831, held by Amneal. Levothyroxine Sodium.
As of Nov 15, 2026, ANDA 210831 (Levothyroxine Sodium), held by Amneal, was first approved by FDA on Feb 19, 2019, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 19, 2019 | Original application | Approved | None posted |
| Levothyroxine Sodium0.025MG · tablet;oral | Levothyroxine Sodium | Discontinued |
| Levothyroxine Sodium0.05MG · tablet;oral | Levothyroxine Sodium | Discontinued |
| Levothyroxine Sodium0.075MG · tablet;oral | Levothyroxine Sodium | Discontinued |
| Levothyroxine Sodium0.088MG · tablet;oral | Levothyroxine Sodium | Discontinued |
| Levothyroxine Sodium0.1MG · tablet;oral | Levothyroxine Sodium | Discontinued |
| Levothyroxine Sodium0.112MG · tablet;oral | Levothyroxine Sodium | Discontinued |
| Levothyroxine Sodium0.125MG · tablet;oral | Levothyroxine Sodium | Discontinued |
| Levothyroxine Sodium0.137MG · tablet;oral | Levothyroxine Sodium | Discontinued |
| Levothyroxine Sodium0.15MG · tablet;oral | Levothyroxine Sodium | Discontinued |
| Levothyroxine Sodium0.175MG · tablet;oral | Levothyroxine Sodium | Discontinued |
| Levothyroxine Sodium0.2MG · tablet;oral | Levothyroxine Sodium | Discontinued |
| Levothyroxine Sodium0.3MG · tablet;oral | Levothyroxine Sodium | Discontinued |
| Aug 26, 2024 | Supplement 4Labeling · Standard review | Approved | None posted |
| Aug 29, 2023 | Supplement 2Labeling · Standard review | Approved | None posted |
| Aug 29, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Feb 19, 2019 | Original application | Approved | None posted |
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
