Sodium Tetradecyl Sulfate Injectable Solution

Brand(s)
Sotradecol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Institutional Llc (2013-04-29)
Oldest Current Product
2004-12-01
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\SODIUM TETRADECYL SULFATE
FDAOB
INJECTION\INJECTION\SODIUM TETRADECYL SULFATE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\TETRADECYL HYDROGEN SULFATE (ESTER)
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\TETRADECYL HYDROGEN SULFATE (ESTER)

product(s) by strength(s)

sodium tetradecyl sulfate 10 mg/ml injectable solution

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1659740162SotradecolANDAAngiodynamics2004-12-01TETRADECYL HYDROGEN SULFATE (ESTER)INTRAVENOUSINJECTION, SOLUTIONANDA0405414749ba52-52d4-431b-8e86-14dcbeec7220
2674570162SotradecolANDAMylan Institutional Llc2013-04-29TETRADECYL HYDROGEN SULFATE (ESTER)INTRAVENOUSINJECTION, SOLUTIONANDA040541f1756c28-dcd2-4b49-be62-07ca20682018

sodium tetradecyl sulfate 30 mg/ml injectable solution

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1659740163SotradecolANDAAngiodynamics2004-12-01TETRADECYL HYDROGEN SULFATE (ESTER)INTRAVENOUSINJECTION, SOLUTIONANDA0405414749ba52-52d4-431b-8e86-14dcbeec7220
2674570163SotradecolANDAMylan Institutional Llc2013-04-29TETRADECYL HYDROGEN SULFATE (ESTER)INTRAVENOUSINJECTION, SOLUTIONANDA040541f1756c28-dcd2-4b49-be62-07ca20682018

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040541SOTRADECOLMYLAN INSTITUTIONAL LLC2004-11-12ANDA040541_001, ANDA040541_002
2NDA005970SOTRADECOLTrueELKINS SINN DIV AH ROBINS CO INCNDA005970_004, NDA005970_005

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1ANDA040541_001RXSODIUM TETRADECYL SULFATE (20MG/2ML)INJECTIONTrue2004-11-12SOTRADECOL
2ANDA040541_002RXSODIUM TETRADECYL SULFATE (60MG/2ML)INJECTIONTrue2004-11-12SOTRADECOL
3NDA005970_004discontinuedSODIUM TETRADECYL SULFATE (1%)INJECTIONFalseSOTRADECOL
4NDA005970_005discontinuedSODIUM TETRADECYL SULFATE (3%)INJECTIONFalseSOTRADECOL

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
14749ba52-52d4-431b-8e86-14dcbeec7220 (view SPL)prescriptionHuman PrescriptionAngiodynamics2013-03-123659740162, 659740163
2f1756c28-dcd2-4b49-be62-07ca20682018 (view SPL)SOTRADECOL (Sodium Tetradecyl Sulfate Injection)prescriptionHuman PrescriptionMylan Institutional Llc2013-04-296674570162, 674570163

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII