LEUKERAN
LEUKERAN (chlorambucil) Tablets
Approved
Approval ID
58a3c995-5ad6-465d-8437-5970c9088213
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 15, 2023
Manufacturers
FDA
Waylis Therapeutics LLC
DUNS: 117678921
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
chlorambucil
PRODUCT DETAILS
NDC Product Code80725-610
Application NumberNDA010669
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateMay 15, 2023
Generic Namechlorambucil
INGREDIENTS (10)
CHLORAMBUCILActive
Quantity: 2 mg in 1 1
Code: 18D0SL7309
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT