FDA.reportPublic FDA data

Application 202440

Type
ANDA
Sponsor
PERRIGO UK FINCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDEBENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATEGEL;TOPICAL5%;EQ 1% BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45802-507clindamycin and benzoyl peroxideclindamycin and benzoyl peroxidePerrigo New York IncANDACurrent
45802-507CLINDAMYCIN AND BENZOYL PEROXIDEclindamycin and benzoyl peroxidePerrigo New York IncANDACurrent
45802-507clindamycin and benzoyl peroxideclindamycin and benzoyl peroxidePerrigo New York IncANDACurrent
45802-507clindamycin and benzoyl peroxideclindamycin and benzoyl peroxidePadagis Israel Pharmaceuticals LtdANDACurrent
45802-507CLINDAMYCIN AND BENZOYL PEROXIDEclindamycin and benzoyl peroxidePadagis Israel Pharmaceuticals LtdANDACurrent
45802-507clindamycin and benzoyl peroxideclindamycin and benzoyl peroxidePerrigo New York IncANDACurrent
45802-507clindamycin and benzoyl peroxideclindamycin and benzoyl peroxidePerrigo New York IncANDACurrent
45802-509clindamycin and benzoyl peroxideclindamycin and benzoyl peroxidePadagis Israel Pharmaceuticals LtdANDACurrent
45802-509clindamycin and benzoyl peroxideclindamycin and benzoyl peroxidePadagis Israel Pharmaceuticals LtdANDACurrent
45802-509clindamycin and benzoyl peroxideclindamycin and benzoyl peroxidePerrigo New York IncANDACurrent
45802-510clindamycin and benzoyl peroxideclindamycin and benzoyl peroxidePerrigo New York IncANDACurrent
45802-510clindamycin and benzoyl peroxideclindamycin and benzoyl peroxidePadagis Israel Pharmaceuticals LtdANDACurrent
45802-510clindamycin and benzoyl peroxideclindamycin and benzoyl peroxidePadagis Israel Pharmaceuticals LtdANDACurrent
70518-2722CLINDAMYCIN AND BENZOYL PEROXIDEclindamycin and benzoyl peroxideREMEDYREPACK INC.ANDACurrent
70518-2722CLINDAMYCIN AND BENZOYL PEROXIDEclindamycin and benzoyl peroxideREMEDYREPACK INC.ANDACurrent
70518-2722CLINDAMYCIN AND BENZOYL PEROXIDEclindamycin and benzoyl peroxideREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10051ORIG2015-09-23