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FDA ANDA · ANDA201970

RASAGILINE

Sponsor: ORBION PHARMS

APPLICATION
ANDA201970
TYPE
ANDA
ORIGINAL APPROVAL
2016-03-15
LATEST ACTION
2020-10-16
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

2020-10-16Labeling · Supplement 5 · standardAP
2020-01-02Labeling · Supplement 4 · standardAP
2020-01-02Labeling · Supplement 1 · standardAP
2016-03-15Not Applicable · OriginalAP
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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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