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

Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Express Scripts
Fish and Richardson
Daiichi Sankyo

Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040541

« Back to Dashboard

NDA 040541 describes SOTRADECOL, which is a drug marketed by Elkins Sinn and Mylan Institutional and is included in two NDAs. It is available from one supplier. Additional details are available on the SOTRADECOL profile page.

The generic ingredient in SOTRADECOL is sodium tetradecyl sulfate. There are one thousand four hundred and twenty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sodium tetradecyl sulfate profile page.
Summary for 040541
Applicant:Mylan Institutional
Ingredient:sodium tetradecyl sulfate
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 040541
Suppliers and Packaging for NDA: 040541
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOTRADECOL sodium tetradecyl sulfate INJECTABLE;INJECTION 040541 ANDA Mylan Institutional LLC 67457-162 N 67457-162-02
SOTRADECOL sodium tetradecyl sulfate INJECTABLE;INJECTION 040541 ANDA Mylan Institutional LLC 67457-163 N 67457-163-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/2ML (10MG/ML)
Approval Date:Nov 12, 2004TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength60MG/2ML (30MG/ML)
Approval Date:Nov 12, 2004TE:RLD:No

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Boehringer Ingelheim
Daiichi Sankyo

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.