ANDA 78941, held by Wockhardt Bio AG. Entacapone.
As of Nov 14, 2026, ANDA 78941 (Entacapone), held by Wockhardt Bio AG, was first approved by FDA on Aug 16, 2012, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 16, 2012 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Entacapone200MG ยท tablet;oral | Entacapone | Rx |
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
