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SOTRADECOL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MYLAN INSTITUTIONAL · Approved 2004-11-12

Drug application

FDA Application #

ANDA040541

Application type

Abbreviated New Drug Application (Generic)

Brand name

SOTRADECOL

Generic name

TETRADECYL HYDROGEN SULFATE (ESTER)

Active ingredients

SODIUM TETRADECYL SULFATE

Dosage form

INJECTABLE

Route

INJECTION

Marketing status

Prescription

Sponsor

MYLAN INSTITUTIONAL

Manufacturer

Mylan Institutional LLC

First approval

2004-11-12

Source

Authoritative

Drugs@FDA application overview

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