← FDA DRUG APPROVALS

FDA NDA · NDA020400

AVITA

Sponsor: RISING

APPLICATION
NDA020400
TYPE
NDA
ORIGINAL APPROVAL
1998-01-29
LATEST ACTION
2015-06-17
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Discontinued

Products

AVITADiscontinued
TRETINOIN 0.025% · GEL · TOPICAL

Approval history

2015-06-17Manufacturing (CMC) · Supplement 6 · standardAP
2011-08-10Labeling · Supplement 5 · unknown — Letter ↗AP
2001-12-06Manufacturing (CMC) · Supplement 3 · standardAP
1999-12-15Manufacturing (CMC) · Supplement 2 · standardAP
1998-01-29Type 5 - New Formulation or New Manufacturer · 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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