← FDA DRUG APPROVALS

FDA ANDA · ANDA202956

ZOLMITRIPTAN OD

zolmitriptan

Sponsor: JUBILANT GENERICS

APPLICATION
ANDA202956
TYPE
ANDA
ORIGINAL APPROVAL
2015-09-17
LATEST ACTION
2025-02-11
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription

Products

ZOLMITRIPTANPrescription
ZOLMITRIPTAN 5MG · TABLET, ORALLY DISINTEGRATING · ORAL
ZOLMITRIPTANPrescription
ZOLMITRIPTAN 2.5MG · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2025-02-11Labeling · Supplement 10 · standardAP
2015-09-17UNKNOWN · OriginalLetterAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →