Manages Parkinson’s disease being treated with levodopa/carbidopa. NDA 21479, held by Bausch. Selegiline Hydrochloride.
As of Nov 14, 2026, NDA 21479 (Zelapar), held by Bausch, was first approved by FDA on Jun 14, 2006, with 6 approved supplements and 0 published complete response letters.
ZELAPAR is indicated as an adjunct in the management of patients with Parkinson’s disease being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. There is no evidence from controlled studies that ZELAPAR has any beneficial effect in the absence of concurrent levodopa therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 14, 2006 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zelapar1.25MG · tablet, orally disintegrating;oral | Selegiline Hydrochloride | DiscontinuedReference drug |
| Jun 16, 2021 | Supplement 10Labeling · Standard review | Approved | |
| Aug 19, 2019 | Supplement 8Labeling · Standard review | Approved | |
| Oct 9, 2015 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jul 31, 2014 | Supplement 5Labeling · Standard review | Approved | |
| Dec 31, 2008 | Supplement 3Labeling · Standard review | Approved | |
| Dec 31, 2008 | Supplement 4Labeling · Standard review | Approved | |
| Jun 14, 2006 | 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
