Anastrozole
These highlights do not include all the information needed to use Anastrozole Tablets safely and effectively. See full prescribing information for Anastrozole Tablets. Anastrozole tablet for oral use Initial U.S. Approval: 1995
Approved
Approval ID
07ccde5f-e6f2-4e9a-b1de-d5adc047f6bc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 16, 2017
Manufacturers
FDA
STASON PHARMACEUTICALS, INC
DUNS: 807437553
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Anastrozole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60763-376
Application NumberANDA078944
Product Classification
M
Marketing Category
C73584
G
Generic Name
Anastrozole
Product Specifications
Route of AdministrationORAL
Effective DateApril 10, 2017
FDA Product Classification
INGREDIENTS (5)
ANASTROZOLEActive
Quantity: 1 mg in 1 1
Code: 2Z07MYW1AZ
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT