.

Make Better Decisions

  • Identify first generic entrants
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

UBS
Dow
Express Scripts
Cipla
Merck
Healthtrust
Cantor Fitzgerald
Fish and Richardson
US Army
Novartis

Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018751

« Back to Dashboard

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 018751

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details

Pharmacology for NDA: 018751

Ingredient-typeAzoles

Medical Subject Heading (MeSH) Categories for 018751

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:RXDosage:CREAM;TOPICALStrength1%
Approval Date:Dec 23, 1982TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 018751

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alvogen MaltaSPECTAZOLEeconazole nitrateCREAM;TOPICAL018751-001Dec 23, 1982► Subscribe► Subscribe
Alvogen MaltaSPECTAZOLEeconazole nitrateCREAM;TOPICAL018751-001Dec 23, 1982► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.



Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Accenture
Citi
McKinsey
Moodys
Cerilliant
Cantor Fitzgerald
Julphar
Daiichi Sankyo
Queensland Health

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot