Treats Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism. NDA 217186, held by Impax. Carbidopa; Levodopa.
As of Nov 13, 2026, NDA 217186 (Crexont), held by Impax, was first approved by FDA on Aug 7, 2024, with 2 approved supplements and 1 published complete response letter.
CREXONT is indicated for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication in adults. CREXONT is a combination of carbidopa (an aromatic amino acid decarboxylation inhibitor) and levodopa (an aromatic amino acid) indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 7, 2024 | Original applicationNew dosage form · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Jun 30, 2023 | Crexont (carbidopa and levodopa) | Approved |
| Crexont35MG;140MG · capsule, extended release;oral | Carbidopa; Levodopa | RxReference drug |
| Crexont52.5MG;210MG · capsule, extended release;oral | Carbidopa; Levodopa | RxReference drug |
| Crexont70MG;280MG · capsule, extended release;oral | Carbidopa; Levodopa | RxReference drug |
| Crexont87.5MG;350MG · capsule, extended release;oral | Carbidopa; Levodopa | RxReference drug |
| May 15, 2026 | Supplement 8Labeling · Standard review | Approved | |
| Mar 19, 2026 | Supplement 11Labeling · Standard review | Approved | |
| Aug 7, 2024 | Original applicationNew dosage form · Standard review | 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
