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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 Mylan Institutional and Elkins Sinn 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 three hundred and thirty-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 NDA: 040541

Mylan Institutional
sodium tetradecyl sulfate
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 040541

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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)
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:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength60MG/2ML (30MG/ML)
Approval Date:Nov 12, 2004TE:RLD:Yes

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