FDA.reportPublic FDA data

Application 019116

Type
NDA
Sponsor
BAUSCH

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16781-391LocoidHYDROCORTISONE BUTYRATEOnset Dermatologics, LLCNDACurrent
16781-391LocoidHYDROCORTISONE BUTYRATEBausch Health US, LLCNDACurrent
16781-391LocoidHYDROCORTISONE BUTYRATEBausch Health US, LLCNDACurrent
16781-391LocoidHYDROCORTISONE BUTYRATEOnset Dermatologics, LLCNDACurrent
68682-273Hydrocortisone Butyratehydrocortisone butyrateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-273Hydrocortisone Butyratehydrocortisone butyrateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-273Hydrocortisone Butyratehydrocortisone butyrateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent
68682-273Hydrocortisone Butyratehydrocortisone butyrateOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
11437SUPPL2014-11-04
1229SUPPL2014-10-31