Application 203640

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NILOTINIB HYDROCHLORIDENILOTINIB HYDROCHLORIDECAPSULE;ORALEQ 50MG BASENoNo
002NILOTINIB HYDROCHLORIDENILOTINIB HYDROCHLORIDECAPSULE;ORALEQ 150MG BASENoNo
003NILOTINIB HYDROCHLORIDENILOTINIB HYDROCHLORIDECAPSULE;ORALEQ 200MG BASENoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77485ORIG 2024-02-14
71678ORIG2022-08-01