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FDA NDA · NDA021450

ZOLMITRIPTAN

Sponsor: AMNEAL

APPLICATION
NDA021450
TYPE
NDA
ORIGINAL APPROVAL
2003-09-30
LATEST ACTION
2018-12-21
ROUTE
NASAL
DOSAGE FORM
SPRAY
MARKETING STATUS
Prescription

Products

ZOMIG · ReferencePrescription
ZOLMITRIPTAN 5MG/SPRAY · SPRAY · NASAL
ZOMIG · ReferencePrescription
ZOLMITRIPTAN 2.5MG/SPRAY · SPRAY · NASAL

Approval history

2018-12-21Labeling · Supplement 10 · standard — Label ↗AP
2015-06-12Efficacy · Supplement 8 · standard — Letter ↗AP
2013-09-16Efficacy · Supplement 7 · standard — Label ↗AP
2008-10-14Efficacy · Supplement 5 · standard — Letter ↗AP
2004-07-02Labeling · Supplement 1 · standard — Letter ↗AP
2003-09-30Type 3 - New Dosage Form · Original · standard — Pediatric Medical 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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