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FDA NDA · NDA021641

AZILECT

rasagiline mesylate

Sponsor: TEVA

APPLICATION
NDA021641
TYPE
NDA
ORIGINAL APPROVAL
2006-05-16
LATEST ACTION
2020-06-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

AZILECT · ReferencePrescription
RASAGILINE MESYLATE EQ 1MG BASE · TABLET · ORAL
AZILECT · ReferencePrescription
RASAGILINE MESYLATE EQ 0.5MG BASE · TABLET · ORAL

Approval history

2020-06-16Labeling · Supplement 21 · standard — Letter ↗AP
2018-12-20Labeling · Supplement 20 · standard — Label ↗AP
2015-12-09Manufacturing (CMC) · Supplement 19 · standardAP
2015-07-20Manufacturing (CMC) · Supplement 18 · standardAP
2014-05-29Labeling · Supplement 16 · standard — Letter ↗AP
2014-05-29Efficacy · Supplement 17 · standard — Letter ↗AP
2009-12-09Efficacy · Supplement 8 · standard — Review ↗AP
2009-12-09Labeling · Supplement 4 · standard — Label ↗AP
2009-12-09Labeling · Supplement 2 · standard — Label ↗AP
2009-12-09Labeling · Supplement 10 · standard — Letter ↗AP
2009-12-09Labeling · Supplement 7 · standard — Label ↗AP
2009-12-09Labeling · Supplement 5 · standard — Label ↗AP
2009-12-09Labeling · Supplement 3 · standard — Letter ↗AP
2006-05-16Type 1 - New Molecular Entity · 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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