FDA.reportPublic FDA data

Application 020521

Type
BLA
Sponsor
ONY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INFASURF PRESERVATIVE FREECALFACTANTSUSPENSION;INTRATRACHEAL35MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61938-456INFASURFCALFACTANTONY Biotech Inc.BLACurrent
61938-456INFASURFCALFACTANTONY Biotech Inc.NDACurrent
61938-456INFASURFCALFACTANTOny, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79478SUPPL 2024-08-26
79468SUPPL 2024-08-26
62242APPL2020-03-23
34761SUPPL2020-03-23
34760ORIG2020-03-23
25104SUPPL2020-03-23
25103ORIG2020-03-23
20699ORIG2020-03-23
2658SUPPL2020-03-23