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FDA NDA · NDA021479

ZELAPAR

selegiline hydrochloride

Sponsor: BAUSCH

APPLICATION
NDA021479
TYPE
NDA
ORIGINAL APPROVAL
2006-06-14
LATEST ACTION
2021-06-16
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription

Products

ZELAPAR · ReferencePrescription
SELEGILINE HYDROCHLORIDE 1.25MG · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2021-06-16Labeling · Supplement 10 · standard — Label ↗AP
2019-08-19Labeling · Supplement 8 · standard — Letter ↗AP
2015-10-09Manufacturing (CMC) · Supplement 7 · standardAP
2014-07-31Labeling · Supplement 5 · standard — Letter ↗AP
2008-12-31Labeling · Supplement 3 · standard — Letter ↗AP
2008-12-31Labeling · Supplement 4 · standard — Label ↗AP
2006-06-14Type 3 - New Dosage Form · Original · standard — Label ↗AP
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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