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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
US Army
Harvard Business School
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Cantor Fitzgerald

Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040541

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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 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

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 67457-162-02 5 VIAL, GLASS in 1 CARTON (67457-162-02) > 2 mL in 1 VIAL, GLASS (67457-162-00)
SOTRADECOL sodium tetradecyl sulfate INJECTABLE;INJECTION 040541 ANDA Mylan Institutional LLC 67457-163 67457-163-02 5 VIAL, GLASS in 1 CARTON (67457-163-02) > 2 mL in 1 VIAL, GLASS (67457-163-00)

Summary for product number 001

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

Summary for product number 002

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

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Serving leading biopharmaceutical companies globally:

Argus Health
Boehringer Ingelheim
Harvard Business School
Queensland Health

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