FDA.reportPublic FDA data

Application 216109

Type
NDA
Sponsor
HIKMA PHARMACEUTICALS USA, INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ANCEFCEFAZOLININJECTABLE;INJECTIONEQ 2GM/VIALNoNo
002ANCEFCEFAZOLININJECTABLE;INJECTIONEQ 3GM/VIALNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80644SUPPL 2024-12-19
80638SUPPL 2024-12-19
74642ORIG 2023-06-28
72297ORIG2022-10-11
72292ORIG2022-10-11