FDA.reportPublic FDA data

Application 020744

Type
BLA
Sponsor
CHIESI USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CUROSURFPORACTANT ALFASUSPENSION;INTRATRACHEAL80MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10122-510Curosurfporactant alfaChiesi USA, Inc.BLACurrent
10122-510Curosurfporactant alfaChiesi USA, Inc.BLACurrent
10122-510Curosurfporactant alfaChiesi USA, Inc.BLACurrent
10122-510Curosurfporactant alfaChiesi USA, Inc.NDACurrent
10122-510Curosurfporactant alfaChiesi USA, Inc.NDACurrent
10122-510Curosurfporactant alfaChiesi USA, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67547SUPPL2021-05-19
67542SUPPL2021-05-18
66398APPL2020-03-23
61333SUPPL2020-03-23
61323SUPPL2020-03-23
35260SUPPL2020-03-23
35259SUPPL2020-03-23
35258ORIG2020-03-23
25678SUPPL2020-03-23
25677SUPPL2020-03-23
25676SUPPL2020-03-23
25675SUPPL2020-03-23
20894ORIG2020-03-23
3249ORIG2020-03-23