FDA.reportPublic FDA data

Application 050756

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENZACLINBENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATEGEL;TOPICAL5%;EQ 1% BASEYesYes
002BENZACLINBENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATEGEL;TOPICAL5%;EQ 1% BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-5190BenzaclinClindamycin phosphate and benzoyl peroxideValeant Pharmaceuticals North America LLCNDACurrent
0187-5190BenzaclinClindamycin phosphate and benzoyl peroxideBausch Health US LLCNDACurrent
0187-5190BenzaclinClindamycin phosphate and benzoyl peroxideBausch Health US LLCNDACurrent
0187-5190BenzaclinClindamycin phosphate and benzoyl peroxideBausch Health Americas, Inc.NDACurrent
68682-190Clindamycin phosphate and benzoyl peroxideClindamycin phosphate and benzoyl peroxideOceanside PharmaceuticalsNDACurrent
68682-190Clindamycin phosphate and benzoyl peroxideClindamycin phosphate and benzoyl peroxideOceanside PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
8205SUPPL2011-03-08
18187SUPPL2011-03-07
39268SUPPL2010-06-24
8204SUPPL2010-06-18
39267SUPPL2009-06-22
8203SUPPL2009-06-17
30461SUPPL2007-06-04
18185SUPPL2007-05-29
30462SUPPL2007-05-01
18186SUPPL2007-04-25
30460SUPPL2005-05-02
18184SUPPL2005-05-02
39266SUPPL2002-08-09
8202SUPPL2002-08-09
42718ORIG2000-12-21
18183ORIG2000-12-21
8201ORIG2000-12-21