ANDA 212601, held by Alembic. Entacapone.
As of Nov 14, 2026, ANDA 212601 (Entacapone), held by Alembic, was first approved by FDA on Jan 4, 2022, with 0 approved supplements and 0 published complete response letters.
INDICATIONS 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 tablets 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 |
|---|---|---|---|
| Jan 4, 2022 | 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
