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FDA NDA · NDA021231

ZOMIG-ZMT

Sponsor: ASTRAZENECA

APPLICATION
NDA021231
TYPE
NDA
ORIGINAL APPROVAL
2001-02-13
LATEST ACTION
2018-12-21
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Discontinued

Products

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ZOLMITRIPTAN 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL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ZOLMITRIPTAN 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2018-12-21Labeling · Supplement 14 · standard — Label ↗AP
2012-09-14Labeling · Supplement 10 · standard — Letter ↗AP
2012-09-14Labeling · Supplement 11 · unknown — Label ↗AP
2010-08-11Labeling · Supplement 9 · standard — Letter ↗AP
2004-01-08Labeling · Supplement 5 · standard — Letter ↗AP
2003-05-21Labeling · Supplement 4 · standard — Letter ↗AP
2002-10-09Labeling · Supplement 3 · standard — Letter ↗AP
2001-12-04Manufacturing (CMC) · Supplement 2 · standardAP
2001-09-17Manufacturing (CMC) · Supplement 1 · standardAP
2001-02-13Type 3 - New Dosage Form · Original · standard — Letter ↗AP
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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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