FDA.reportPublic FDA data

Application 018514

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOCOIDHYDROCORTISONE BUTYRATECREAM;TOPICAL0.1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16781-382LocoidHYDROCORTISONE BUTYRATEOnset Dermatologics, LLCNDACurrent
16781-382LocoidHYDROCORTISONE BUTYRATEBausch Health US, LLCNDACurrent
16781-382LocoidHYDROCORTISONE BUTYRATEBausch Health US, LLCNDACurrent
16781-382LocoidHYDROCORTISONE BUTYRATEBausch Health US, LLCNDACurrent
21695-971Hydrocortisone ButyrateHydrocortisone ButyrateRebel Distributors CorpNDACurrent
68682-270HYDROCORTISONE BUTYRATEHYDROCORTISONE BUTYRATEOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-270HYDROCORTISONE BUTYRATEHYDROCORTISONE BUTYRATEOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-270HYDROCORTISONE BUTYRATEHYDROCORTISONE BUTYRATEOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-270HYDROCORTISONE BUTYRATEHYDROCORTISONE BUTYRATEOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
33502SUPPL2014-11-04
15023SUPPL2014-10-31
15022SUPPL2005-12-15
15021SUPPL2002-05-22