FASLODEX
These highlights do not include all the information needed to use FASLODEX safely and effectively. See full prescribing information for FASLODEX. FASLODEX (fulvestrant) injection, for intramuscular useInitial U.S. Approval: 2002
Approved
Approval ID
83d7a440-e904-4e36-afb5-cb02b1c919f7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 25, 2020
Manufacturers
FDA
AstraZeneca Pharmaceuticals LP
DUNS: 054743190
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fulvestrant
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0310-0720
Application NumberNDA021344
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fulvestrant
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateSeptember 25, 2020
FDA Product Classification
INGREDIENTS (5)
FULVESTRANTActive
Quantity: 50 mg in 1 mL
Code: 22X328QOC4
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BENZYL BENZOATEInactive
Code: N863NB338G
Classification: IACT
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT