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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 020541

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NDA 020541 describes ARIMIDEX, which is a drug marketed by Ani Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the ARIMIDEX profile page.

The generic ingredient in ARIMIDEX is anastrozole. There are twenty-four drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the anastrozole profile page.

Summary for 020541

Tradename:	ARIMIDEX
Applicant:	Ani Pharms
Ingredient:	anastrozole
Patents:	0

Pharmacology for NDA: 020541

Mechanism of Action	Aromatase Inhibitors

Suppliers and Packaging for NDA: 020541

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ARIMIDEX	anastrozole	TABLET;ORAL	020541	NDA	ANI Pharmaceuticals, Inc.	62559-670	62559-670-30	30 TABLET in 1 BOTTLE (62559-670-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Dec 27, 1995	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020541

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	ARIMIDEX	anastrozole	TABLET;ORAL	020541-001	Dec 27, 1995	4,935,437	⤷ Get Started Free
Ani Pharms	ARIMIDEX	anastrozole	TABLET;ORAL	020541-001	Dec 27, 1995	RE36617*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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