ANDA 90613, held by Strides Pharma Intl. Torsemide.
As of Nov 15, 2026, ANDA 90613 (Torsemide), held by Strides Pharma Intl, was first approved by FDA on Mar 22, 2011, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 22, 2011 | Original application | Approved | None posted |
| Nov 7, 2012 | Supplement 6Labeling · Standard review | Approved | None posted |
| Mar 22, 2011 | 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
