ANDA 76764, held by Mylan. Levothyroxine Sodium.
As of Nov 15, 2026, ANDA 76764 (Levothyroxine Sodium), held by Mylan, was first approved by FDA on Jun 23, 2004, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 23, 2004 | Original application | Approved |
| Levothyroxine Sodium0.025MG · tablet; oral | Levothyroxine Sodium | Discontinued |
| Levothyroxine Sodium0.050MG · 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 Sodium0.15MG · 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
