"60505-3802-0" National Drug Code (NDC)

Nilotinib 1 BLISTER PACK in 1 CARTON (60505-3802-0) / 28 CAPSULE in 1 BLISTER PACK
(Apotex Corp.)

NDC Code60505-3802-0
Package Description1 BLISTER PACK in 1 CARTON (60505-3802-0) / 28 CAPSULE in 1 BLISTER PACK
Product NDC60505-3802
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameNilotinib
Non-Proprietary NameNilotinib
Dosage FormCAPSULE
UsageORAL
Start Marketing Date20250325
Marketing Category NameANDA
Application NumberANDA203640
ManufacturerApotex Corp.
Substance NameNILOTINIB
Strength200
Strength Unitmg/1
Pharmacy ClassesBcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA]

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