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FDA NDA · NDA021145

VANIQA

Sponsor: ABBVIE

APPLICATION
NDA021145
TYPE
NDA
ORIGINAL APPROVAL
2000-07-27
LATEST ACTION
2016-02-29
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

VANIQA · ReferenceDiscontinued
EFLORNITHINE HYDROCHLORIDE 13.9% · CREAM · TOPICAL

Approval history

2016-02-29Manufacturing (CMC) · Supplement 10 · standardAP
2013-08-30Manufacturing (CMC) · Supplement 9 · standardAP
2013-07-22Manufacturing (CMC) · Supplement 8 · standardAP
2001-09-05Manufacturing (CMC) · Supplement 5 · standard — Review ↗AP
2001-06-29Manufacturing (CMC) · Supplement 3 · standard — Review ↗AP
2001-06-25Manufacturing (CMC) · Supplement 2 · standard — Review ↗AP
2000-12-15Manufacturing (CMC) · Supplement 1 · standard — Review ↗AP
2000-07-27Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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