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 useInitial U.S. Approval: 2002
Approved
Approval ID
29010790-9257-4f70-a5ca-64038f0cc504
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 30, 2021
Manufacturers
FDA
Sandoz Inc
DUNS: 005387188
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 Code0781-3079
Application NumberANDA205935
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fulvestrant
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateApril 15, 2019
FDA Product Classification
INGREDIENTS (5)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FULVESTRANTActive
Quantity: 50 mg in 1 mL
Code: 22X328QOC4
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
BENZYL BENZOATEInactive
Code: N863NB338G
Classification: IACT