FDA.reportPublic FDA data

Application 215033

Type
NDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENDAMUSTINE HYDROCHLORIDEBENDAMUSTINE HYDROCHLORIDESOLUTION; INJECTION25MG/MLNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78151SUPPL 2024-04-16
78145SUPPL 2024-04-16
75377ORIG 2023-09-08
72835ORIG2022-12-09
70744ORIG2022-04-11