FDA.reportPublic FDA data

Application 022076

Type
NDA
Sponsor
BAUSCH

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16781-392LocoidHYDROCORTISONE BUTYRATEBausch Health US, LLCNDACurrent
16781-392LocoidHYDROCORTISONE BUTYRATEBausch Health US LLCNDACurrent
16781-392LocoidHYDROCORTISONE BUTYRATEBausch Health US LLCNDACurrent
16781-392LocoidHYDROCORTISONE BUTYRATEOnset Dermatologics, LLCNDACurrent
16781-392LocoidHYDROCORTISONE BUTYRATEBausch Health US LLCNDACurrent
16781-392LocoidHYDROCORTISONE BUTYRATEBausch Health US LLCNDACurrent
68682-392HYDROCORTISONE BUTYRATEHYDROCORTISONE BUTYRATEOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-392HYDROCORTISONE BUTYRATEHYDROCORTISONE BUTYRATEOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-392HYDROCORTISONE BUTYRATEHYDROCORTISONE BUTYRATEOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75860SUPPL 2023-10-19
75844SUPPL 2023-10-19
38193SUPPL2014-11-04
6832SUPPL2014-10-31
21927ORIG2009-12-17
16902ORIG2007-05-29
6831ORIG2007-05-29