FDA.reportPublic FDA data

Application 208574

Type
NDA
Sponsor
TEVA PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROMIDEPSINROMIDEPSINSOLUTION;INTRAVENOUS10MG/2ML (5MG/ML)YesNo
002ROMIDEPSINROMIDEPSINSOLUTION;INTRAVENOUS27.5MG/5.5ML (5MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0703-3071RomidepsinRomidepsinTeva Parenteral Medicines, Inc.NDACurrent
0703-4004RomidepsinRomidepsinTeva Parenteral Medicines, Inc.NDACurrent
0703-4004RomidepsinRomidepsinTeva Parenteral Medicines, Inc.NDACurrent
0703-4004RomidepsinRomidepsinTeva Parenteral Medicines, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69535SUPPL2021-12-13
69521SUPPL2021-12-09
64880ORIG2020-10-08
64879ORIG2020-10-08
62159ORIG2020-03-17
62158ORIG2020-03-17
62143ORIG2020-03-16
62142ORIG2020-03-16