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FDA ANDA · ANDA040541
SOTRADECOL
tetradecyl hydrogen sulfate (ester)
Sponsor: MYLAN INSTITUTIONAL
APPLICATION
ANDA040541
TYPE
ANDA
ORIGINAL APPROVAL
2004-11-12
LATEST ACTION
2019-05-22
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
SOTRADECOLPrescription
SODIUM TETRADECYL SULFATE 20MG/2ML (10MG/ML) · INJECTABLE · INJECTION
SOTRADECOLPrescription
SODIUM TETRADECYL SULFATE 60MG/2ML (30MG/ML) · INJECTABLE · INJECTION
Approval history
2019-05-22Labeling · Supplement 15 · standardAP
2018-03-01Labeling · Supplement 14 · standardAP
2008-05-30Labeling · Supplement 4AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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