FDA.reportPublic FDA data

Application 050819

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACANYABENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATEGEL;TOPICAL2.5%;EQ 1.2% BASEYesYes
002ONEXTONBENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATEGEL;TOPICAL3.75%;EQ 1.2% BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-3050ONEXTONClindamycin Phosphate and Benzoyl PeroxideValeant Pharmaceuticals North America LLCNDACurrent
0187-3050ONEXTONClindamycin Phosphate and Benzoyl PeroxideBausch Health US, LLCNDACurrent
0187-3050ONEXTONClindamycin Phosphate and Benzoyl PeroxideBausch Health US, LLCNDACurrent
13548-132AcanyaClindamycin Phosphate and Benzoyl PeroxideBausch Health US, LLCNDACurrent
13548-132AcanyaClindamycin Phosphate and Benzoyl PeroxideBausch Health US, LLCNDACurrent
13548-132AcanyaClindamycin Phosphate and Benzoyl PeroxideBausch Health US, LLCNDACurrent
13548-132ACANYAClindamycin Phosphate and Benzoyl PeroxideValent Pharmaceuticals North AmericaNDACurrent
68682-132Clindamycin Phosphate and Benzoyl PeroxideClindamycin Phosphate and Benzoyl PeroxideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-132Clindamycin Phosphate and Benzoyl PeroxideClindamycin Phosphate and Benzoyl PeroxideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-132Clindamycin Phosphate and Benzoyl PeroxideClindamycin Phosphate and Benzoyl PeroxideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-132Clindamycin Phosphate and Benzoyl PeroxideClindamycin Phosphate and Benzoyl PeroxideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61978SUPPL2020-02-27
61977SUPPL2020-02-27
61953SUPPL2020-02-25
61952SUPPL2020-02-25
58715SUPPL2019-05-15
39388SUPPL2014-11-26
30613SUPPL2014-11-26
30612SUPPL2014-03-05
39387SUPPL2014-03-04
30611SUPPL2010-10-20
18299SUPPL2010-10-18
18298SUPPL2010-07-01
30610SUPPL2010-06-29
42754ORIG2009-10-29
24349ORIG2009-10-29
39386ORIG2008-11-07
30609ORIG2008-10-29
63512ORIG1900-01-01
63511ORIG1900-01-01
63510ORIG1900-01-01