LEUKERAN
LEUKERAN (chlorambucil) Tablets
Approved
Approval ID
e3d7a0f9-d704-4676-b16e-622ff6d22aa2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2022
Manufacturers
FDA
Woodward Pharma Services LLC
DUNS: 080406260
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
chlorambucil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69784-610
Application NumberNDA010669
Product Classification
M
Marketing Category
C73594
G
Generic Name
chlorambucil
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2022
FDA Product Classification
INGREDIENTS (10)
CHLORAMBUCILActive
Quantity: 2 mg in 1 1
Code: 18D0SL7309
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT