ANDA 216414, held by Aurobindo Pharma. Levothyroxine Sodium.
As of Nov 15, 2026, ANDA 216414 (Levothyroxine Sodium), held by Aurobindo Pharma, was first approved by FDA on Jul 16, 2024, with 0 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 |
|---|---|---|---|
| Jul 16, 2024 | Original application | Approved | None posted |
| 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 |
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
