FDA.reportPublic FDA data

Application 019600

Type
NDA
Sponsor
BAUSCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXSORALEN-ULTRAMETHOXSALENCAPSULE;ORAL10MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0187-0650Oxsoralen-UltraMethoxsalenBausch Health US, LLCNDACurrent
0187-0650Oxsoralen-UltraMethoxsalenValeant Pharmaceuticals North America LLCNDACurrent
0187-0650Oxsoralen-UltraMethoxsalenBausch Health Americas, Inc.NDACurrent
68682-065MethoxsalenMethoxsalenOceanside PharmaceuticalsNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
1415SUPPL2003-04-15
1414SUPPL2003-04-15
11560SUPPL2003-03-28
11559SUPPL2003-03-26