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Serving 500+ biopharmaceutical companies globally:

Covington
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Medtronic
Dow
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McKesson
AstraZeneca
Johnson and Johnson
QuintilesIMS
Colorcon

Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018751

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NDA 018751 describes SPECTAZOLE, which is a drug marketed by Alvogen Malta and is included in one NDA. It is available from one supplier. Additional details are available on the SPECTAZOLE profile page.

The generic ingredient in SPECTAZOLE 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 NDA: 018751

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for NDA: 018751

Ingredient-typeAzoles

Suppliers and Packaging for NDA: 018751

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SPECTAZOLE
econazole nitrate
CREAM;TOPICAL 018751 NDA Alvogen Inc. 47781-543 47781-543-72 1 TUBE in 1 CARTON (47781-543-72) > 15 g in 1 TUBE
SPECTAZOLE
econazole nitrate
CREAM;TOPICAL 018751 NDA Alvogen Inc. 47781-543 47781-543-73 1 TUBE in 1 CARTON (47781-543-73) > 30 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CREAM;TOPICALStrength1%
Approval Date:Dec 23, 1982TE:RLD:Yes

Expired Orange Book Patents for NDA: 018751

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alvogen Malta
SPECTAZOLE
econazole nitrate
CREAM;TOPICAL018751-001Dec 23, 19823,717,655► Subscribe
Alvogen Malta
SPECTAZOLE
econazole nitrate
CREAM;TOPICAL018751-001Dec 23, 19823,839,574► Subscribe
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Serving 500+ biopharmaceutical companies globally:

McKinsey
AstraZeneca
Julphar
QuintilesIMS
Deloitte
Baxter
Moodys
US Army
Medtronic
Federal Trade Commission

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.

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