Manages levodopa/carbidopa. ANDA 75321, held by Apotex. Selegiline Hydrochloride.
As of Nov 15, 2026, ANDA 75321 (Selegiline Hydrochloride), held by Apotex, was first approved by FDA on Dec 4, 1998, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Selegiline capsules, USP are indicated as an adjunct in the management of Parkinsonian patients 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 selegiline has any beneficial effect in the absence of concurrent levodopa therapy. Evidence supporting this claim was obtained in randomized controlled clinical investigations that compared the effects of added selegiline or placebo in patients receiving levodopa/carbidopa.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 4, 1998 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Selegiline Hydrochloride5MG · capsule;oral | Selegiline Hydrochloride | Rx |
| May 31, 2011 | Supplement 6Labeling | Approved | None posted |
| Nov 30, 2010 | Supplement 5Labeling | Approved | None posted |
| Aug 6, 2010 | Supplement 4Labeling | Approved | None posted |
| Jun 16, 1999 | Supplement 1Manufacturing | Approved | None posted |
| Dec 4, 1998 | Original application | 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
