FDA.reportPublic FDA data

Application 209445

Type
NDA
Sponsor
SHIONOGI INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FETROJACEFIDEROCOL SULFATE TOSYLATEPOWDER;INTRAVENOUSEQ 1GM BASE/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59630-266FetrojaCefiderocol sulfate tosylateShionogi Inc.NDACurrent
59630-266FetrojaCefiderocol sulfate tosylateShionogi Inc.NDACurrent
59630-266FetrojaCefiderocol sulfate tosylateShionogi Inc.NDACurrent
59630-266FetrojaCefiderocol sulfate tosylateShionogi Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82507SUPPL 2025-06-09
82493SUPPL 2025-06-09
69312SUPPL2021-11-15
69308SUPPL2021-11-15
64882SUPPL2020-10-08
64738SUPPL2020-09-29
64694SUPPL2020-09-28
61345ORIG2019-12-19
60850ORIG2019-11-15
60846ORIG2019-11-15