FDA.reportPublic FDA data

Application 050557

Type
NDA
Sponsor
VALEANT INTL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENZAMYCINBENZOYL PEROXIDE; ERYTHROMYCINGEL;TOPICAL5%;3%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-5205Benzamycinerythromycin and benzoyl peroxideBausch Health US, LLCNDACurrent
0187-5205Benzamycinerythromycin and benzoyl peroxideBausch Health US, LLCNDACurrent
0187-5205Benzamycinerythromycin and benzoyl peroxideValeant Pharmaceuticals North America LLCNDACurrent
0187-5205Benzamycinerythromycin and benzoyl peroxideBausch Health US, LLCNDACurrent
45802-083Erythromycin-Benzoyl Peroxideerythromycin and benzoyl peroxidePerrigo New York IncNDA AUTHORIZED GENERICCurrent
45802-083Erythromycin-Benzoyl Peroxideerythromycin and benzoyl peroxidePerrigo New York IncNDA AUTHORIZED GENERICCurrent
68682-900Erythromycin and Benzoyl PeroxideErythromycin and Benzoyl PeroxideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-900Erythromycin and Benzoyl PeroxideErythromycin and Benzoyl PeroxideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-901Erythromycin and Benzoyl PeroxideErythromycin and Benzoyl PeroxideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-901Erythromycin and Benzoyl PeroxideErythromycin and Benzoyl PeroxideOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
17871SUPPL2003-03-06