"0832-0533-03" National Drug Code (NDC)

Imatinib Mesylate 30 TABLET in 1 BOTTLE (0832-0533-03)
(Upsher-Smith Laboratories, LLC)

NDC Code0832-0533-03
Package Description30 TABLET in 1 BOTTLE (0832-0533-03)
Product NDC0832-0533
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameImatinib Mesylate
Non-Proprietary NameImatinib Mesylate
Dosage FormTABLET
UsageORAL
Start Marketing Date20240517
Marketing Category NameANDA
Application NumberANDA212135
ManufacturerUpsher-Smith Laboratories, LLC
Substance NameIMATINIB MESYLATE
Strength400
Strength Unitmg/1
Pharmacy ClassesBcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Kinase Inhibitor [EPC]

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