"81927-201-01" National Drug Code (NDC)

Imkeldi 140 mL in 1 BOTTLE (81927-201-01)
(Shorla Oncology Inc.,)

NDC Code81927-201-01
Package Description140 mL in 1 BOTTLE (81927-201-01)
Product NDC81927-201
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameImkeldi
Non-Proprietary NameImatinib Oral
Dosage FormSOLUTION
UsageORAL
Start Marketing Date20241219
Marketing Category NameNDA
Application NumberNDA219097
ManufacturerShorla Oncology Inc.,
Substance NameIMATINIB MESYLATE
Strength80
Strength Unitmg/mL
Pharmacy ClassesBcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]

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