Treats myxedema coma. NDA 210632, held by Fresenius Kabi USA. Levothyroxine Sodium.
As of Nov 13, 2026, NDA 210632 (Levothyroxine Sodium), held by Fresenius Kabi USA, was first approved by FDA on Apr 11, 2019, with 0 approved supplements and 0 published complete response letters.
Levothyroxine Sodium Injection is indicated for the treatment of myxedema coma. Levothyroxine Sodium Injection is L-thyroxine (T4) indicated in adult patients for the treatment of myxedema coma. Limitations of Use: Not recommended as a substitute for oral levothyroxine sodium because the relative bioavailability of Levothyroxine Sodium Injection to oral levothyroxine sodium has not been established and there is a risk of inaccurate dose conversion.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 11, 2019 | Original applicationNew dosage form · Standard review | Approved |
| Levothyroxine Sodium100MCG/5ML (20MCG/ML) · solution;intravenous | Levothyroxine Sodium | RxReference drug |
| Levothyroxine Sodium200MCG/5ML (40MCG/ML) · solution;intravenous | Levothyroxine Sodium | RxReference drug |
| Levothyroxine Sodium500MCG/5ML (100MCG/ML) · solution;intravenous | Levothyroxine Sodium | RxReference drug |
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
