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FDA ANDA · ANDA091441

NARATRIPTAN

Sponsor: ORBION PHARMS

APPLICATION
ANDA091441
TYPE
ANDA
ORIGINAL APPROVAL
2012-04-30
LATEST ACTION
2020-03-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

NARATRIPTANPrescription
NARATRIPTAN HYDROCHLORIDE EQ 2.5MG BASE · TABLET · ORAL
NARATRIPTANPrescription
NARATRIPTAN HYDROCHLORIDE EQ 1MG BASE · TABLET · ORAL

Approval history

2020-03-16Labeling · Supplement 2 · standardAP
2015-09-10Labeling · Supplement 1 · standardAP
2012-04-30OriginalAP
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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