FDA.reportPublic FDA data

Application 103362

Type
BLA
Sponsor
BERLEX LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEUKINESARGRAMOSTIMVIAL250UG/MLNoNo
002LEUKINESARGRAMOSTIMVIAL500UG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0024-5843LeukineSARGRAMOSTIMsanofi-aventis U.S. LLCBLACurrent
0024-5844LeukineSARGRAMOSTIMsanofi-aventis U.S. LLCBLACurrent
71837-5843LeukineSARGRAMOSTIMPartner Therapeutics, IncBLACurrent
71837-5843LeukineSARGRAMOSTIMPartner Therapeutics, IncBLACurrent
71837-5843LeukineSARGRAMOSTIMPartner Therapeutics, IncBLACurrent
71837-5843LeukineSARGRAMOSTIMPartner Therapeutics, IncBLACurrent
71837-5843LeukineSARGRAMOSTIMPartner Therapeutics, IncBLACurrent
71837-5843LeukineSARGRAMOSTIMPartner Therapeutics, IncBLACurrent
71837-5844LeukineSARGRAMOSTIMPartner Therapeutics, IncBLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71024SUPPL2022-05-07
71006SUPPL2022-05-06
53577SUPPL2018-04-01
62323SUPPL2018-03-29
53549SUPPL2018-03-29
47179SUPPL2017-02-13
47178SUPPL2017-02-10