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Generated: December 18, 2018

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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 and fifty-four 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
Tradename:SOTRADECOL
Applicant:Mylan Institutional
Ingredient:sodium tetradecyl sulfate
Patents:0
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)

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

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