← FDA DRUG APPROVALS

FDA NDA · NDA019334

SELEGILINE HYDROCHLORIDE

Sponsor: QUAGEN

APPLICATION
NDA019334
TYPE
NDA
ORIGINAL APPROVAL
1989-06-05
LATEST ACTION
2008-12-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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SELEGILINE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2008-12-31Labeling · Supplement 19 · standard — Letter ↗AP
2008-12-31Labeling · Supplement 20 · standard — Letter ↗AP
1997-08-06Labeling · Supplement 17 · standardAP
1994-07-13Manufacturing (CMC) · Supplement 12 · priorityAP
1993-02-12Manufacturing (CMC) · Supplement 11 · priorityAP
1993-01-05Manufacturing (CMC) · Supplement 6 · priorityAP
1993-01-05Manufacturing (CMC) · Supplement 9 · priorityAP
1993-01-05Labeling · Supplement 7AP
1993-01-05Labeling · Supplement 5AP
1993-01-05Manufacturing (CMC) · Supplement 8 · priorityAP
1990-07-25Labeling · Supplement 3AP
1990-03-26Labeling · Supplement 1AP
1990-03-01Manufacturing (CMC) · Supplement 2 · priorityAP
1989-06-05Type 1 - New Molecular Entity · Original · priorityAP
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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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