ANDA 75152, held by Watson Labs Teva. Diclofenac Potassium.
As of Nov 15, 2026, ANDA 75152 (Diclofenac Potassium), held by Watson Labs Teva, was first approved by FDA on Nov 27, 1998, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 27, 1998 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Diclofenac Potassium50MG ยท tablet;oral | Diclofenac Potassium | Discontinued |
| Nov 7, 2002 | Supplement 3Manufacturing | Approved | None posted |
| Aug 31, 2001 | Supplement 2Manufacturing | Approved | None posted |
| Nov 10, 1999 | Supplement 1Manufacturing | Approved | None posted |
| Nov 27, 1998 | Original application | Approved |
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