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
67566681-19b5-89df-2030-25df5b0cf641
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 23, 2021
Manufacturers
FDA
Northstar Rx, LLC,
DUNS: 830546433
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 Code16714-070
Application NumberANDA213553
Product Classification
M
Marketing Category
C73584
G
Generic Name
fulvestrant
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateAugust 23, 2021
FDA Product Classification
INGREDIENTS (5)
FULVESTRANTActive
Quantity: 50 mg in 1 mL
Code: 22X328QOC4
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
BENZYL BENZOATEInactive
Code: N863NB338G
Classification: IACT