FDA.reportPublic FDA data

Application 050782

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLINDAGELCLINDAMYCIN PHOSPHATEGEL;TOPICALEQ 1% BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16781-462ClindagelCLINDAMYCINBausch Health US LLCNDACurrent
16781-462ClindagelCLINDAMYCINBausch Health US, LLCNDACurrent
16781-462ClindagelCLINDAMYCINOnset Dermatologics LLCNDACurrent
68682-462Clindamycin PhosphateClindamycin PhosphateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-462Clindamycin PhosphateClindamycin PhosphateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22237ORIG2004-07-15
39325ORIG2003-05-02
30529ORIG2000-11-27