← FDA DRUG APPROVALS

FDA NDA · NDA019963

RENOVA

Sponsor: VALEANT PHARMS NORTH

APPLICATION
NDA019963
TYPE
NDA
ORIGINAL APPROVAL
1995-12-29
LATEST ACTION
2013-01-08
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Discontinued

Products

RENOVA · ReferenceDiscontinued
TRETINOIN 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CREAM · TOPICAL

Approval history

2013-01-08Manufacturing (CMC) · Supplement 15 · standardAP
2001-03-20Manufacturing (CMC) · Supplement 8 · standardAP
2000-08-01Labeling · Supplement 7 · standard — Letter ↗AP
2000-08-01Efficacy · Supplement 5 · unknown — Letter ↗AP
1999-01-25Manufacturing (CMC) · Supplement 6 · standardAP
1998-07-23Manufacturing (CMC) · Supplement 4 · standardAP
1998-02-20Labeling · Supplement 3 · standardAP
1996-08-19Manufacturing (CMC) · Supplement 2 · standardAP
1996-08-09Manufacturing (CMC) · Supplement 1 · standardAP
1995-12-29Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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