ANDA 76350, held by Btg Intl. Potassium Iodide.
As of Nov 15, 2026, ANDA 76350 (Thyrosafe), held by Btg Intl, was first approved by FDA on Sep 10, 2002, with 3 approved supplements and 0 published complete response letters.
DIRECTIONS FOR USE Use only as directed by public officials if a nuclear radiation emergency happens.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 10, 2002 | Original application | Approved | None posted |
| Thyrosafe65MG · tablet;oral | Potassium Iodide | OTC |
| Thyrosafe130MG · tablet;oral | Potassium Iodide | OTC |
| Feb 13, 2004 | Supplement 4Labeling | Approved | None posted |
| May 21, 2003 | Supplement 2Labeling | Approved | None posted |
| Apr 30, 2003 | Supplement 1Labeling | Approved | None posted |
| Sep 10, 2002 | Original application | Approved | None posted |
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
