FDA.reportPublic FDA data

Anastrozole

Product NDC
71335-0023
11-digit product format
713350023
Labeler code
71335
Product ID
71335-0023_12fe2a29-6543-45aa-b04e-a4cdb3f66143
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Anastrozole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA200654
Marketing category
ANDA
Marketing start
2012-05-31
Marketing end
0000-00-00
Substance
ANASTROZOLE
Active strength
1 mg/1
Pharmacologic classes
Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71335-0023DDiscontinued by firm2026-07-31
excluded packagepackage71335-002371335-0023-1DDiscontinued by firm2026-07-31
excluded packagepackage71335-002371335-0023-2DDiscontinued by firm2026-07-31
excluded packagepackage71335-002371335-0023-3DDiscontinued by firm2026-07-31
excluded packagepackage71335-002371335-0023-4DDiscontinued by firm2026-07-31
excluded packagepackage71335-002371335-0023-5DDiscontinued by firm2026-07-31
excluded packagepackage71335-002371335-0023-6DDiscontinued by firm2026-07-31
excluded packagepackage71335-002371335-0023-7DDiscontinued by firm2026-07-31
excluded packagepackage71335-002371335-0023-8DDiscontinued by firm2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200654-001ANASTROZOLEANASTROZOLE1MGTABLET / ORAL2012-05-11