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
03fb3108-1856-466d-bf88-0eac96139551
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 4, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-2453
Application NumberANDA090568
Product Classification
M
Marketing Category
C73584
G
Generic Name
Anastrozole
Product Specifications
Route of AdministrationORAL
Effective DateOctober 21, 2020
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
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
POLYETHYLENE GLYCOL 300Inactive
Code: 5655G9Y8AQ
Classification: IACT
ANASTROZOLEActive
Quantity: 1 mg in 1 1
Code: 2Z07MYW1AZ
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT