Treats myxedema coma. ANDA 217066, held by Zydus Pharms. Levothyroxine Sodium.
As of Nov 15, 2026, ANDA 217066 (Levothyroxine Sodium), held by Zydus Pharms, was first approved by FDA on Mar 24, 2023, with 0 approved supplements and 0 published complete response letters.
Levothyroxine sodium for injection is indicated for the treatment of myxedema coma. Important Limitations of Use: The relative bioavailability between levothyroxine sodium for injection and oral levothyroxine products has not been established. Caution should be used when switching patients from oral levothyroxine products to levothyroxine sodium for injection as accurate dosing conversion has not been studied. Levothyroxine sodium is an L-thyroxine product.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 24, 2023 | Original application | Approved | None posted |
| Levothyroxine Sodium100MCG/VIAL · powder;intravenous | Levothyroxine Sodium | Rx |
| Levothyroxine Sodium200MCG/VIAL · powder;intravenous | Levothyroxine Sodium | Rx |
| Levothyroxine Sodium500MCG/VIAL · powder;intravenous | 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
