← FDA DRUG APPROVALS

FDA ANDA · ANDA202431

NARATRIPTAN

Sponsor: AUROBINDO PHARMA USA

APPLICATION
ANDA202431
TYPE
ANDA
ORIGINAL APPROVAL
2012-05-31
LATEST ACTION
2020-10-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2020-10-20Labeling · Supplement 3 · standardAP
2015-09-16Labeling · Supplement 1 · standardAP
2012-05-31UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →