FULVESTRANT
Fulvestrant Injection
Approved
Approval ID
151b948a-3106-497a-b1c7-479307faeb89
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 26, 2022
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
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 Code70771-1626
Application NumberANDA215234
Product Classification
M
Marketing Category
C73584
G
Generic Name
fulvestrant
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateAugust 26, 2022
FDA Product Classification
INGREDIENTS (5)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BENZYL BENZOATEInactive
Code: N863NB338G
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
FULVESTRANTActive
Quantity: 50 mg in 1 mL
Code: 22X328QOC4
Classification: ACTIB