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
e46ed5b8-83c9-4adb-890f-0fc612371eea
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 5, 2019
Manufacturers
FDA
Major Pharmaceuticals
DUNS: 191427277
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 Code0904-6195
Application NumberANDA090568
Product Classification
M
Marketing Category
C73584
G
Generic Name
Anastrozole
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 3, 2018
FDA Product Classification
INGREDIENTS (8)
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
ANASTROZOLEActive
Quantity: 1 mg in 1 1
Code: 2Z07MYW1AZ
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT