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 tablets, for oral use. Initial U.S. Approval: 1995
Approved
Approval ID
7d792fea-6bf9-0994-e053-2a91aa0a20c1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2018
Manufacturers
FDA
medsource pharmaceuticals
DUNS: 833685915
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 Code45865-909
Application NumberANDA090568
Product Classification
M
Marketing Category
C73584
G
Generic Name
Anastrozole
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2018
FDA Product Classification
INGREDIENTS (8)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ANASTROZOLEActive
Quantity: 1 mg in 1 1
Code: 2Z07MYW1AZ
Classification: ACTIB