FDA.reportPublic FDA data

Application 202497

Type
NDA
Sponsor
ACROTECH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MARQIBO KITVINCRISTINE SULFATEINJECTABLE, LIPOSOMAL;INTRAVENOUS5MG/5ML (1MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
20536-322MarqiboVincristine SulfateTalon Therapeutics, Inc.NDACurrent
72893-008MarqiboVincristine SulfateAcrotech Biopharma LLCNDACurrent
72893-008MarqiboVincristine SulfateAcrotech Biopharma LLCNDACurrent
72893-008MarqiboVincristine SulfateAcrotech Biopharma LLCNDACurrent
72893-008MarqiboVincristine SulfateAcrotech Biopharma LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70552SUPPL2022-03-17
70528SUPPL2022-03-16
63825SUPPL2020-07-08
63468SUPPL2020-06-09
63465SUPPL2020-06-09
61513SUPPL2020-01-06
44858ORIG2013-09-03
43404ORIG2013-09-03
32267ORIG2012-08-10
19353ORIG2012-08-09