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
46086fe7-190d-4963-97bc-1fe22d36e6d2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 25, 2023
Manufacturers
FDA
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
DUNS: 542977621
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 Code71731-6121
Application NumberANDA211422
Product Classification
M
Marketing Category
C73584
G
Generic Name
fulvestrant
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateJanuary 25, 2023
FDA Product Classification
INGREDIENTS (5)
benzyl alcoholInactive
Code: LKG8494WBH
Classification: IACT
fulvestrantActive
Quantity: 50 mg in 1 mL
Code: 22X328QOC4
Classification: ACTIB
alcoholInactive
Code: 3K9958V90M
Classification: IACT
benzyl benzoateInactive
Code: N863NB338G
Classification: IACT
castor oilInactive
Code: D5340Y2I9G
Classification: IACT