Manages thyrotropin-dependent well-differentiated thyroid cancer. ANDA 215259, held by Ascent Pharms Inc. Levothyroxine Sodium.
As of Nov 15, 2026, ANDA 215259 (Levothyroxine Sodium), held by Ascent Pharms Inc, was first approved by FDA on Jan 18, 2023, with 0 approved supplements and 0 published complete response letters.
Hypothyroidism Levothyroxine sodium tablets are indicated as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression Levothyroxine sodium tablets are indicated as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 18, 2023 | 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
