Treats myxedema coma. ANDA 208749, held by Maia Pharms Inc. Levothyroxine Sodium.
As of Nov 15, 2026, ANDA 208749 (Levothyroxine Sodium), held by Maia Pharms Inc, was first approved by FDA on Dec 21, 2018, 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 |
|---|---|---|---|
| Dec 21, 2018 | 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
