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Serving leading biopharmaceutical companies globally:

Express Scripts
Fish and Richardson
Boehringer Ingelheim
Harvard Business School
Daiichi Sankyo

Generated: February 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076075

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NDA 076075 describes ECONAZOLE NITRATE, which is a drug marketed by Fougera Pharms, Perrigo New York, Taro, and Teligent Pharma Inc, and is included in four NDAs. It is available from eight suppliers. Additional details are available on the ECONAZOLE NITRATE profile page.

The generic ingredient in ECONAZOLE NITRATE is econazole nitrate. There are eleven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the econazole nitrate profile page.
Summary for 076075
Applicant:Fougera Pharms
Ingredient:econazole nitrate
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Pharmacology for NDA: 076075
Medical Subject Heading (MeSH) Categories for 076075
Suppliers and Packaging for NDA: 076075
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ECONAZOLE NITRATE econazole nitrate CREAM;TOPICAL 076075 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0312 N 0168-0312-30
ECONAZOLE NITRATE econazole nitrate CREAM;TOPICAL 076075 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0312 N 0168-0312-85

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Nov 26, 2002TE:ABRLD:No

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