ANDA 205792, held by Ajanta Pharma Ltd. Entacapone.
As of Nov 14, 2026, ANDA 205792 (Entacapone), held by Ajanta Pharma Ltd, was first approved by FDA on Aug 31, 2017, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Entacapone tablets are indicated as an adjunct to levodopa and carbidopa to treat end-of-dose “wearing-off” in patients with Parkinson’s disease (see CLINICAL PHARMACOLOGY, Clinical Studies ). Entacapone tablet’s effectiveness has not been systematically evaluated in patients with Parkinson’s disease who do not experience end-of-dose “wearing-off”.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 31, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Entacapone200MG · 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
