ANDA 205366, held by Ph Health. Levothyroxine Sodium.
As of Nov 15, 2026, ANDA 205366 (Levothyroxine Sodium), held by Ph Health, was first approved by FDA on Dec 7, 2015, with 0 approved supplements and 0 published complete response letters.
| Dec 7, 2015 | Original application | Approved | |
| Dec 7, 2015 | Original application | Tentative approval | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Levothyroxine Sodium200MCG/VIAL ยท 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
