ANDA 212399, held by Accord Hlthcare. Levothyroxine Sodium.
As of Nov 15, 2026, ANDA 212399 (Levothyroxine Sodium), held by Accord Hlthcare, was first approved by FDA on Oct 19, 2020, with 5 approved supplements and 0 published complete response letters.
Hypothyroidism Levothyroxine sodium tablets are indicated in adult and pediatric patients, including neonates, 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
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 19, 2020 | 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 |
| Sep 16, 2024 | Supplement 8Labeling · Standard review | Approved | None posted |
| Sep 16, 2024 | Supplement 6Labeling · Standard review | Approved | None posted |
| Oct 31, 2022 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Sep 16, 2022 | Supplement 4Manufacturing | Approved | None posted |
| Sep 16, 2022 | Supplement 3Manufacturing | Approved | None posted |
| Oct 19, 2020 | 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
