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Last Updated: July 2, 2020

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Details for New Drug Application (NDA): 020726


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NDA 020726 describes FEMARA, which is a drug marketed by Novartis Pharms and is included in one NDA. It is available from one supplier. Additional details are available on the FEMARA profile page.

The generic ingredient in FEMARA is letrozole. There are twenty-four drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the letrozole profile page.
Summary for 020726
Tradename:FEMARA
Applicant:Novartis Pharms
Ingredient:letrozole
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020726
Mechanism of ActionAromatase Inhibitors
Suppliers and Packaging for NDA: 020726
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FEMARA letrozole TABLET;ORAL 020726 NDA Novartis Pharmaceuticals Corporation 0078-0249 0078-0249-15 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0249-15)
Paragraph IV (Patent) Challenges for 020726
Tradename Dosage Ingredient NDA Submissiondate
FEMARA TABLET;ORAL letrozole 020726 2006-03-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Jul 25, 1997TE:ABRLD:Yes

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