← FDA DRUG APPROVALS

FDA NDA · NDA021001

AXERT

Sponsor: JANSSEN PHARMS

APPLICATION
NDA021001
TYPE
NDA
ORIGINAL APPROVAL
2001-05-07
LATEST ACTION
2017-05-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

AXERT · ReferenceDiscontinued
ALMOTRIPTAN MALATE EQ 6.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
AXERT · ReferenceDiscontinued
ALMOTRIPTAN MALATE EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2017-05-15Labeling · Supplement 15 · standard — Label ↗AP
2014-08-07Labeling · Supplement 14 · standard — Letter ↗AP
2009-04-30Efficacy · Supplement 11 · priority — Label ↗AP
2009-04-30Labeling · Supplement 10 · standard — Label ↗AP
2009-03-27Labeling · Supplement 9 · standard — Letter ↗AP
2009-03-27Labeling · Supplement 8 · standard — Letter ↗AP
2009-01-13UNKNOWN · Supplement 18 · unknown — Pediatric Written Request ↗AP
2004-06-01Labeling · Supplement 2 · standard — Letter ↗AP
2001-05-07Type 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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