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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69784-620
Application NumberNDA009386
Product Classification
M
Marketing Category
C73594
G
Generic Name
busulfan
Product Specifications
Route of AdministrationORAL
Effective DateApril 15, 2022
FDA Product Classification
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