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
b33520de-f891-43f8-bd04-1b66795d3dd2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 6, 2011
Manufacturers
FDA
Synthon Pharmaceuticals, Inc.
DUNS: 013502302
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 Code63672-0015
Application NumberANDA078322
Product Classification
M
Marketing Category
C73584
G
Generic Name
Anastrozole
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 6, 2011
FDA Product Classification
INGREDIENTS (8)
AnastrozoleActive
Quantity: 1 mg in 1 1
Code: 2Z07MYW1AZ
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
polyethylene glycolInactive
Code: 3WJQ0SDW1A
Classification: IACT
sodium starch glycolate type a potatoInactive
Code: 5856J3G2A2
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT