sodium thiosulfate Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hope Pharmaceuticals (2012-12-17)
Oldest Current Product
2012-02-14
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\SODIUM THIOSULFATE
FDAOB
INTRAVENOUS\SOLUTION\SODIUM THIOSULFATE
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\SODIUM THIOSULFATE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\SODIUM CATION: THIOSULFATE ION

product(s) by strength(s)

sodium thiosulfate 250 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1602670705NDAHope Pharmaceuticals2012-02-14SODIUM THIOSULFATEINTRAVENOUSINJECTION, SOLUTIONNDA20392382f55408-2de9-463d-85e8-b39c3b259f0b

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203923SODIUM THIOSULFATEHOPE PHARMACEUTICALS2012-02-14p8496973, TREATMENT OF ACUTE CYANIDE POISONING THAT IS JUDGED TO BE LIFE THREATENING, SUBSTANCEORPHAN DRUG EXCLUSIVITY [2018-01-14]NDA203923_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203923_001RXSODIUM THIOSULFATE (12.5GM/50ML)INTRAVENOUSSOLUTIONTrue2012-02-14SODIUM THIOSULFATE

patent(s)

#idexpiration dateapplication(s)
1p8496973 (view patent)2031-03-29NDA203923, NDA201444

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
182f55408-2de9-463d-85e8-b39c3b259f0b (view SPL)These highlights do not include all the information needed to use the Sodium Thiosulfate Injection safely and effectively. See full prescribing information for Sodium Thiosulfate Injection. Sodium Thiosulfate Injection, USP Initial U.S. Approval: 1992prescriptionHuman PrescriptionHope PharmaceuticalsMANUFACTURE2012-12-173602670705

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