Manages levodopa/carbidopa. ANDA 74871, held by Apotex. Selegiline Hydrochloride.
As of Nov 15, 2026, ANDA 74871 (Selegiline Hydrochloride), held by Apotex, was first approved by FDA on Jun 6, 1997, with 5 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Selegiline Hydrochloride Tablets 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 |
|---|---|---|---|
| Jun 6, 1997 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Selegiline Hydrochloride5MG · tablet;oral | Selegiline Hydrochloride | Rx |
| Dec 1, 2009 | Supplement 9Labeling | Approved | None posted |
| Aug 18, 1999 | Supplement 4Manufacturing | Approved | None posted |
| Jun 16, 1999 | Supplement 1Manufacturing | Approved | None posted |
| Jun 16, 1999 | Supplement 2Labeling | Approved | None posted |
| Oct 20, 1998 | Supplement 3Labeling | Approved | None posted |
| Jun 6, 1997 | Original application | Approved | None posted |
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
