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Last Updated: June 10, 2023

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
Applicant:Ani Pharms
Formulation / Manufacturing:see details
Pharmacology for NDA: 020541
Mechanism of ActionAromatase 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:RXDosage:TABLET;ORALStrength1MG
Approval Date:Dec 27, 1995TE:ABRLD:Yes

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