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FDA NDA · NDA020768

ZOMIG

Sponsor: IPR

APPLICATION
NDA020768
TYPE
NDA
ORIGINAL APPROVAL
1997-11-25
LATEST ACTION
2018-12-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ZOMIG · ReferenceDiscontinued
ZOLMITRIPTAN 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ZOMIG · ReferenceDiscontinued
ZOLMITRIPTAN 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2018-12-21Labeling · Supplement 23 · standard — Label ↗AP
2014-03-12Manufacturing (CMC) · Supplement 22 · standardAP
2012-09-14Labeling · Supplement 19 · standard — Letter ↗AP
2012-09-14Labeling · Supplement 21 · unknown — Label ↗AP
2010-08-11Labeling · Supplement 17 · standard — Letter ↗AP
2004-11-16Efficacy · Supplement 12 · priority — Pediatric Medical Review ↗AP
2004-01-08Labeling · Supplement 13 · standard — Letter ↗AP
2003-05-21Labeling · Supplement 11 · standard — Letter ↗AP
2002-10-09Labeling · Supplement 10 · standard — Review ↗AP
2002-01-29Labeling · Supplement 6 · standard — Letter ↗AP
2000-12-18Manufacturing (CMC) · Supplement 9 · standardAP
2000-09-12Manufacturing (CMC) · Supplement 8 · standardAP
2000-05-01Labeling · Supplement 3 · standardAP
2000-03-09Manufacturing (CMC) · Supplement 7 · standardAP
2000-02-14Manufacturing (CMC) · Supplement 5 · standardAP
1999-11-29Manufacturing (CMC) · Supplement 4 · standardAP
1999-02-16Manufacturing (CMC) · Supplement 2 · standardAP
1998-07-21Manufacturing (CMC) · Supplement 1 · standardAP
1997-11-25Type 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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