Fulvestrant
These highlights do not include all the information needed to use FULVESTRANT INJECTION safely and effectively. See full prescribing information for FULVESTRANT INJECTION. FULVESTRANT injection, for intramuscular use Initial U.S. Approval: 2002
Approved
Approval ID
80b6dfe6-449d-4e2f-af90-bfbf9b04163b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 26, 2023
Manufacturers
FDA
Eugia US LLC
DUNS: 968961354
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 Code55150-394
Application NumberANDA215169
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fulvestrant
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJuly 26, 2023
FDA Product Classification
INGREDIENTS (5)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FULVESTRANTActive
Quantity: 50 mg in 1 mL
Code: 22X328QOC4
Classification: ACTIB
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
BENZYL BENZOATEInactive
Code: N863NB338G
Classification: IACT