APPLICATION
ANDA201889
TYPE
ANDA
ORIGINAL APPROVAL
2017-10-30
LATEST ACTION
2021-01-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
RASAGILINE MESYLATEPrescription
RASAGILINE MESYLATE EQ 1MG BASE · TABLET · ORAL
RASAGILINE MESYLATEPrescription
RASAGILINE MESYLATE EQ 0.5MG BASE · TABLET · ORAL
Approval history
2021-01-14Labeling · Supplement 4 · standardAP
2020-01-02Labeling · Supplement 3 · standardAP
2017-10-30Not 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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