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FDA NDA · NDA021005

SOLARAZE

Sponsor: FOUGERA

APPLICATION
NDA021005
TYPE
NDA
ORIGINAL APPROVAL
2000-10-16
LATEST ACTION
2024-11-21
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Discontinued

Products

SOLARAZE · ReferenceDiscontinued
DICLOFENAC SODIUM 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · GEL · TOPICAL

Approval history

2024-11-21Labeling · Supplement 25 · standard — Letter ↗AP
2022-11-14Labeling · Supplement 24 · standard — Letter ↗AP
2022-04-05Labeling · Supplement 23 · standard — Label ↗AP
2021-04-28Labeling · Supplement 22 · standard — Letter ↗AP
2016-05-16Manufacturing (CMC) · Supplement 17 · standardAP
2016-05-09Labeling · Supplement 16 · standard — Letter ↗AP
2015-03-30Manufacturing (CMC) · Supplement 15 · standardAP
2011-12-08Labeling · Supplement 13 · unknown — Label ↗AP
2007-06-01Manufacturing (CMC) · Supplement 10 · standard — Letter ↗AP
2004-07-23Manufacturing (CMC) · Supplement 9 · standard — Letter ↗AP
2004-03-18Manufacturing (CMC) · Supplement 7 · standard — Letter ↗AP
2003-04-29Labeling · Supplement 6 · standard — Letter ↗AP
2002-12-13Manufacturing (CMC) · Supplement 5 · standardAP
2002-05-20Manufacturing (CMC) · Supplement 4 · standardAP
2002-02-19Manufacturing (CMC) · Supplement 3 · standardAP
2001-10-02Manufacturing (CMC) · Supplement 2 · standardAP
2001-08-17Labeling · Supplement 1 · standardAP
2000-10-16Type 3 - New Dosage Form · Original · standard — Letter ↗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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