MYLERAN

MYLERAN

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 117678921

Effective Date

May 15, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Busulfan(2 mg in 1 1)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

80725-620

Application Number

NDA009386

Marketing Category

NDA (C73594)

Route of Administration

ORAL

Effective Date

May 15, 2023

Ingredients

Code: G1LN9045DKClass: ACTIBQuantity: 2 mg in 1 1

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMKClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

TRIACETINInactive

Code: XHX3C3X673Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT