MYLERAN
MYLERAN (busulfan) Tablets
Approved
Approval ID
2da33e5b-dcfb-4cdf-b163-50398e42f41c
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.
busulfan
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code80725-620
Application NumberNDA009386
Product Classification
M
Marketing Category
C73594
G
Generic Name
busulfan
Product Specifications
Route of AdministrationORAL
Effective DateMay 15, 2023
FDA Product Classification
INGREDIENTS (7)
BUSULFANActive
Quantity: 2 mg in 1 1
Code: G1LN9045DK
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT