Treats myxedema coma. ANDA 206163, held by Piramal Critical. Levothyroxine Sodium.
As of Nov 15, 2026, ANDA 206163 (Levothyroxine Sodium), held by Piramal Critical, was first approved by FDA on Jun 29, 2016, 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 |
|---|---|---|---|
| Jun 29, 2016 | Original application | Approved |
| Levothyroxine Sodium100MCG/VIAL · powder;intravenous | Levothyroxine Sodium | Discontinued |
| Levothyroxine Sodium500MCG/VIAL · powder;intravenous | 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
