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FDA NDA · NDA022239

SUMAVEL DOSEPRO

Sponsor: ENDO OPERATIONS

APPLICATION
NDA022239
TYPE
NDA
ORIGINAL APPROVAL
2009-07-15
LATEST ACTION
2020-07-02
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

SUMAVEL DOSEPRO · ReferenceDiscontinued
SUMATRIPTAN SUCCINATE EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML) · INJECTABLE · SUBCUTANEOUS
SUMAVEL DOSEPRO · ReferenceDiscontinued
SUMATRIPTAN SUCCINATE EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML) · INJECTABLE · SUBCUTANEOUS

Approval history

2020-07-02Labeling · Supplement 7 · standard — Letter ↗AP
2019-12-26Labeling · Supplement 6 · standard — Letter ↗AP
2016-06-02Manufacturing (CMC) · Supplement 4 · standard — Label ↗AP
2013-11-26Efficacy · Supplement 5 · standard — Label ↗AP
2011-06-27Labeling · Supplement 2 · unknown — Label ↗AP
2009-07-15Type 3 - New Dosage Form · Original · standard — Summary 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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