← FDA DRUG APPROVALS

FDA NDA · NDA020763

AMERGE

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APPLICATION
NDA020763
TYPE
NDA
ORIGINAL APPROVAL
1998-02-10
LATEST ACTION
2016-11-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

AMERGE · ReferenceDiscontinued
NARATRIPTAN HYDROCHLORIDE EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
AMERGE · ReferenceDiscontinued
NARATRIPTAN HYDROCHLORIDE EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2016-11-29Labeling · Supplement 11 · standard — Letter ↗AP
2013-10-16Labeling · Supplement 1 · standard — Letter ↗AP
2013-10-16Labeling · Supplement 10 · standard — Letter ↗AP
2013-10-16Labeling · Supplement 2 · standard — Letter ↗AP
2012-03-02Labeling · Supplement 9 · unknown — Letter ↗AP
2012-03-02Labeling · Supplement 8 · standard — Label ↗AP
2010-08-11Labeling · Supplement 6 · standard — Letter ↗AP
2003-10-27Labeling · Supplement 5 · standard — Letter ↗AP
2001-09-07Manufacturing (CMC) · Supplement 4 · standardAP
2000-07-21Manufacturing (CMC) · Supplement 3 · standardAP
1998-02-10Type 1 - New Molecular Entity · Original · standard — Review ↗AP
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.

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