ANASTROZOLE

Basic Information

Product Name

ANASTROZOLE

FDA Product Code

42291-016

Regulatory Information

NDC Product Code

42291-016

Application Number

ANDA079220

Marketing Category

C73584

Effective Date

February 6, 2023

Territorial Authority

USA

FDA Title

ANASTROZOLE TABLETS, USP Rx Only These highlights do not include all the information needed to use ANASTROZOLE TABLETS safely and effectively. See full prescribing information for ANASTROZOLE TABLETS. Initial U.S. Approval: 1995

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POVIDONE, UNSPECIFIED

Code: FZ989GH94E

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

ANASTROZOLE

Quantity: 1 mg in 1 1

Code: 2Z07MYW1AZ

Class Code: ACTIB

Active Moieties

Code: 2Z07MYW1AZ

ANASTROZOLE

Basic Information

Regulatory Information

Company Information

Active Ingredients

LACTOSE MONOHYDRATE

POLYETHYLENE GLYCOL, UNSPECIFIED

MAGNESIUM STEARATE

POVIDONE, UNSPECIFIED

HYPROMELLOSE, UNSPECIFIED

SODIUM STARCH GLYCOLATE TYPE A POTATO

TITANIUM DIOXIDE

Active Moieties

ANASTROZOLE