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"65162-795-09" National Drug Code (NDC)

Imatinib Mesylate 90 TABLET, FILM COATED in 1 BOTTLE (65162-795-09)
(Amneal Pharmaceuticals LLC)

NDC Code65162-795-09
Package Description90 TABLET, FILM COATED in 1 BOTTLE (65162-795-09)
Product NDC65162-795
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameImatinib Mesylate
Non-Proprietary NameImatinib
Dosage FormTABLET, FILM COATED
UsageORAL
Start Marketing Date20190208
Marketing Category NameANDA
Application NumberANDA207495
ManufacturerAmneal Pharmaceuticals 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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