FDA.reportPublic FDA data

Application 205397

Type
ANDA
Sponsor
PERRIGO ISRAEL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEBENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATEGEL;TOPICAL2.5%;EQ 1.2% BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45802-597Clindamycin Phosphate and Benzoyl PeroxideClindamycin Phosphate, Benzoyl PeroxidePerrigo New York IncANDACurrent
45802-597Clindamycin Phosphate and Benzoyl PeroxideClindamycin Phosphate, Benzoyl PeroxidePerrigo New York IncANDACurrent
45802-597Clindamycin Phosphate and Benzoyl PeroxideClindamycin Phosphate, Benzoyl PeroxidePadagis Israel Pharmaceuticals LtdANDACurrent
63629-8635Clindamycin Phosphate and Benzoyl PeroxideClindamycin Phosphate, Benzoyl PeroxideBryant Ranch PrepackANDACurrent
63629-8635Clindamycin Phosphate and Benzoyl PeroxideClindamycin Phosphate, Benzoyl PeroxideBryant Ranch PrepackANDACurrent
63629-8635Clindamycin Phosphate and Benzoyl PeroxideClindamycin Phosphate, Benzoyl PeroxideBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
50060ORIG2017-10-13