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
f36f19ad-f044-4dba-80b6-d074ddffcd86
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 25, 2021
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 827748190
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 Code70121-1463
Application NumberANDA210044
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fulvestrant
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateJanuary 25, 2021
FDA Product Classification
INGREDIENTS (5)
FULVESTRANTActive
Quantity: 250 mg in 5 mL
Code: 22X328QOC4
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
BENZYL BENZOATEInactive
Code: N863NB338G
Classification: IACT
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT