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FDA NDA · NDA050756

BENZACLIN

Sponsor: BAUSCH

APPLICATION
NDA050756
TYPE
NDA
ORIGINAL APPROVAL
2000-12-21
LATEST ACTION
2014-12-05
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Discontinued

Products

BENZACLIN · ReferenceDiscontinued
BENZOYL PEROXIDE 5%, CLINDAMYCIN PHOSPHATE EQ 1% BASE · GEL · TOPICAL
BENZACLINDiscontinued
BENZOYL PEROXIDE 5%, CLINDAMYCIN PHOSPHATE EQ 1% BASE · GEL · TOPICAL

Approval history

2014-12-05Manufacturing (CMC) · Supplement 44 · standardAP
2014-09-22Manufacturing (CMC) · Supplement 43 · standardAP
2011-03-02Manufacturing (CMC) · Supplement 40 · standard — Letter ↗AP
2010-06-17Labeling · Supplement 37 · unknown — Letter ↗AP
2010-06-14Manufacturing (CMC) · Supplement 35AP
2009-06-12Labeling · Supplement 34 · standard — Letter ↗AP
2007-05-23Labeling · Supplement 26 · standard — Label ↗AP
2007-04-20Manufacturing (CMC) · Supplement 27 — Label ↗AP
2005-04-28Labeling · Supplement 16 · standard — Label ↗AP
2002-08-28Manufacturing (CMC) · Supplement 9 · standardAP
2002-08-09Manufacturing (CMC) · Supplement 7 · standard — Label ↗AP
2002-06-27Manufacturing (CMC) · Supplement 8 · standardAP
2002-03-26Manufacturing (CMC) · Supplement 6 · standardAP
2001-10-12Manufacturing (CMC) · Supplement 3 · standardAP
2001-09-26Manufacturing (CMC) · Supplement 5 · standardAP
2001-09-25Manufacturing (CMC) · Supplement 4 · standardAP
2001-08-30Manufacturing (CMC) · Supplement 2 · standardAP
2001-04-17Manufacturing (CMC) · Supplement 1 · standardAP
2000-12-21Type 4 - New Combination · Original · standard — Review ↗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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