ANDA 216370, held by Alembic. Levothyroxine Sodium.
As of Nov 15, 2026, ANDA 216370 (Levothyroxine Sodium), held by Alembic, was first approved by FDA on May 20, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 20, 2026 | Original application | Approved | None posted |
| Levothyroxine Sodium0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levothyroxine Sodium0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levothyroxine Sodium0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levothyroxine Sodium0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levothyroxine Sodium0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levothyroxine Sodium0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levothyroxine Sodium0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levothyroxine Sodium0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levothyroxine Sodium0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levothyroxine Sodium0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levothyroxine Sodium0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | Rx |
| Levothyroxine Sodium0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · tablet;oral | Levothyroxine Sodium | 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
