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FDA NDA · NDA022377

ALSUMA

Sponsor: MERIDIAN MEDCL

APPLICATION
NDA022377
TYPE
NDA
ORIGINAL APPROVAL
2010-06-29
LATEST ACTION
2014-06-05
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ALSUMADiscontinued
SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) · INJECTABLE · SUBCUTANEOUS

Approval history

2014-06-05Labeling · Supplement 4 · standard — Label ↗AP
2014-06-05Labeling · Supplement 2 · standard — Label ↗AP
2013-04-15Manufacturing (CMC) · Supplement 3 · standardAP
2010-06-29Type 3 - New Dosage Form · Original · standard — Label ↗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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