APPLICATION
ANDA090381
TYPE
ANDA
ORIGINAL APPROVAL
2010-07-07
LATEST ACTION
2021-04-23
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
2021-04-23Labeling · Supplement 3 · standardAP
2015-09-14Labeling · Supplement 2 · standardAP
2011-10-11Labeling · Supplement 1AP
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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