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FDA ANDA · ANDA207004

RASAGILINE

Sponsor: MICRO LABS

APPLICATION
ANDA207004
TYPE
ANDA
ORIGINAL APPROVAL
2019-03-29
LATEST ACTION
2020-10-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

RASAGILINE MESYLATEPrescription
RASAGILINE MESYLATE EQ 0.5MG BASE · TABLET · ORAL
RASAGILINE MESYLATEPrescription
RASAGILINE MESYLATE EQ 1MG BASE · TABLET · ORAL

Approval history

2020-10-16Labeling · Supplement 2 · standardAP
2019-03-29UNKNOWN · Original · standardAP
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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