Sodium Nitrite 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 NITRITE
FDAOB
INTRAVENOUS\SOLUTION\SODIUM NITRITE
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\SODIUM NITRITE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\NITRITE ION: SODIUM CATION

product(s) by strength(s)

sodium nitrite 30 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1602670311NDAHope Pharmaceuticals2012-02-14SODIUM NITRITEINTRAVENOUSINJECTION, SOLUTIONNDA20392252f01c6e-172a-47a9-98a6-9eab7651a032

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203922SODIUM NITRITEHOPE PHARMACEUTICALS2012-02-14p8568793, SUBSTANCEORPHAN DRUG EXCLUSIVITY [2018-01-14]NDA203922_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203922_001RXSODIUM NITRITE (300MG/10ML)INTRAVENOUSSOLUTIONTrue2012-02-14SODIUM NITRITE

patent(s)

#idexpiration dateapplication(s)
1p8568793 (view patent)2031-12-24NDA203922, NDA201444

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
152f01c6e-172a-47a9-98a6-9eab7651a032 (view SPL)These highlights do not include all the information needed to use Sodium Nitrite Injection safely and effectively. See full prescribing information for Sodium Nitrite Injection.Sodium Nitrite Injection, USPInitial U.S. Approval: 2011prescriptionHuman PrescriptionHope PharmaceuticalsMANUFACTURE2012-12-173602670311

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