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FDA NDA · NDA020647

ELDEPRYL

Sponsor: QUAGEN

APPLICATION
NDA020647
TYPE
NDA
ORIGINAL APPROVAL
1996-05-15
LATEST ACTION
2013-05-20
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

ELDEPRYL · ReferenceDiscontinued
SELEGILINE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2013-05-20Manufacturing (CMC) · Supplement 8 · standardAP
2008-12-31Labeling · Supplement 7 · standard — Label ↗AP
2008-12-31Labeling · Supplement 6 · standard — Letter ↗AP
2001-02-15Manufacturing (CMC) · Supplement 4 · standardAP
1997-08-06Labeling · Supplement 3 · standard — Review ↗AP
1996-05-15Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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