APPLICATION
ANDA201950
TYPE
ANDA
ORIGINAL APPROVAL
2013-09-12
LATEST ACTION
2015-12-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
RASAGILINE MESYLATEDiscontinued
RASAGILINE MESYLATE EQ 0.5MG BASE · TABLET · ORAL
RASAGILINE MESYLATEDiscontinued
RASAGILINE MESYLATE EQ 1MG BASE · TABLET · ORAL
Approval history
2015-12-17Labeling · Supplement 1 · standardAP
2013-09-12Not Applicable · OriginalAP
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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