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Details for New Drug Application (NDA): 205175

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NDA 205175 describes ECOZA, which is a drug marketed by Exeltis Suisse and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the ECOZA profile page.

The generic ingredient in ECOZA is econazole nitrate. There are eleven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the econazole nitrate profile page.

Summary for NDA: 205175

Exeltis Suisse
econazole nitrate
Therapeutic Class:Antifungals

Pharmacology for NDA: 205175


Suppliers and Packaging for NDA: 205175

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
econazole nitrate
AEROSOL, FOAM;TOPICAL 205175 NDA Exeltis USA Dermatology, LLC 23710-100 23710-100-10 1 CAN in 1 CARTON (23710-100-10) > 10 g in 1 CAN
econazole nitrate
AEROSOL, FOAM;TOPICAL 205175 NDA Exeltis USA Dermatology, LLC 23710-100 23710-100-70 1 CAN in 1 CARTON (23710-100-70) > 70 g in 1 CAN

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:AEROSOL, FOAM;TOPICALStrength1%
Approval Date:Oct 24, 2013TE:RLD:Yes
Patent:5,993,830Patent Expiration:Jan 16, 2018Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Oct 24, 2016
Regulatory Exclusivity Use:NEW DOSAGE FORM

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.