ANDA 90642, held by Watson Labs Inc. Valsartan.
As of Nov 14, 2026, ANDA 90642 (Valsartan), held by Watson Labs Inc, was first approved by FDA on Jan 5, 2015, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 5, 2015 | Original application | Approved | None posted |
| Jun 30, 2020 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jun 30, 2020 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jan 5, 2015 | 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