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FDA NDA · NDA021108

RENOVA

tretinoin

Sponsor: VALEANT PHARMS NORTH

APPLICATION
NDA021108
TYPE
NDA
ORIGINAL APPROVAL
2000-08-31
LATEST ACTION
2016-05-25
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

RENOVA · ReferencePrescription
TRETINOIN 0.02% · CREAM · TOPICAL

Approval history

2016-05-25Manufacturing (CMC) · Supplement 18 · standardAP
2014-09-22Manufacturing (CMC) · Supplement 16 · standardAP
2014-06-13Manufacturing (CMC) · Supplement 15 · standard — Label ↗AP
2013-01-08Manufacturing (CMC) · Supplement 13 · standardAP
2002-07-14Labeling · Supplement 1 · standard — Letter ↗AP
2001-04-06Manufacturing (CMC) · Supplement 2 · standardAP
2001-03-20Manufacturing (CMC) · Supplement 3 · standardAP
2000-08-31Type 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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