ANDA 78478, held by Sun Pharm Inds. Torsemide.
As of Nov 15, 2026, ANDA 78478 (Torsemide), held by Sun Pharm Inds, was first approved by FDA on Feb 26, 2008, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 26, 2008 | Original application | Approved | None posted |
| Sep 28, 2010 | Supplement 3Labeling | Approved | None posted |
| Feb 26, 2008 | 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
