Anastrozole
ANASTROZOLE tablets -------------------------------- These highlights do not include all the information needed to use ANASTROZOLE TABLETS safely and effectively. See full prescribing information for ANASTROZOLE TABLETS ANASTROZOLE TABLETS for oral use Initial U.S. Approval: 1995
Approved
Approval ID
f86d2158-b078-3f74-e053-6394a90aa4b6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 17, 2023
Manufacturers
FDA
Avet Pharmaceuticals Inc
DUNS: 780779901
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Anastrozole Tablets
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code23155-857
Application NumberANDA206037
Product Classification
M
Marketing Category
C73584
G
Generic Name
Anastrozole Tablets
Product Specifications
Route of AdministrationORAL
Effective DateApril 17, 2023
FDA Product Classification
INGREDIENTS (9)
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANASTROZOLEActive
Quantity: 1 mg in 1 1
Code: 2Z07MYW1AZ
Classification: ACTIB