MYLERAN
MYLERAN (busulfan) Tablets
Approved
Approval ID
00ca5f69-8944-47f8-8ebf-98b0b8062c20
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.
busulfan
PRODUCT DETAILS
NDC Product Code69784-620
Application NumberNDA009386
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateApril 15, 2022
Generic Namebusulfan
INGREDIENTS (7)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
BUSULFANActive
Quantity: 2 mg in 1 1
Code: G1LN9045DK
Classification: ACTIB
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT