← FDA DRUG APPROVALS

FDA NDA · NDA021415

METVIXIA

Sponsor: GALDERMA LABS LP

APPLICATION
NDA021415
TYPE
NDA
ORIGINAL APPROVAL
2004-07-27
LATEST ACTION
2012-11-20
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

METVIXIADiscontinued
METHYL AMINOLEVULINATE HYDROCHLORIDE EQ 16.8% BASE · CREAM · TOPICAL

Approval history

2012-11-20Labeling · Supplement 4 · standard — Label ↗AP
2008-06-26Efficacy · Supplement 3 · standard — Letter ↗AP
2005-05-31Labeling · Supplement 1 · standard — Letter ↗AP
2004-07-27Type 3 - New Dosage Form · Original · standard — 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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