Dantrolene Injectable Solution

Brand(s)
Dantrium, Revonto
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Par Pharmaceutical Inc. (2014-05-07)
Oldest Current Product
2008-08-01
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\DANTROLENE
FDAOB
INJECTION\INJECTION\DANTROLENE SODIUM\rdfq
SPL Active
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\DANTROLENE SODIUM
INTRAVENOUS\INJECTION\DANTROLENE SODIUM
SPL Moiety
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\DANTROLENE
INTRAVENOUS\INJECTION\DANTROLENE

product(s) by strength(s)

dantrolene sodium 0.333 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1420230123DantriumNDAPar Pharmaceutical Inc.2008-08-01DANTROLENE SODIUMINTRAVENOUSINJECTIONNDA0182644df35098-8702-46be-ac67-30cfdf1aa570

generic product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1275050003RevontoANDAUs Worldmeds, Llc2012-06-042017-03-31DANTROLENE SODIUMINTRAVENOUSINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONANDA0783780055d78a-9dc2-4267-8c9e-c3f2c98a66ff, 78801254-73a0-44ca-9222-7b3581af82d8

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA078378REVONTOUS WORLDMEDS LLC2007-07-24ANDA078378_001
2NDA018264DANTRIUMPAR STERILE PRODUCTS LLCNDA018264_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA078378_001RXDANTROLENE SODIUM (20MG/VIAL)INJECTIONFalseAP2007-07-24REVONTO
2NDA018264_001RXDANTROLENE SODIUM (20MG/VIAL)INJECTIONTrueAPDANTRIUM

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10055d78a-9dc2-4267-8c9e-c3f2c98a66ff (view SPL)Revonto (dantrolene sodium for injection)prescriptionHuman PrescriptionUs Worldmeds, Llc2014-12-122275050003
24df35098-8702-46be-ac67-30cfdf1aa570 (view SPL)prescriptionHuman PrescriptionPar Pharmaceutical Inc.2014-05-075420230123
378801254-73a0-44ca-9222-7b3581af82d8 (view SPL)Revonto (dantrolene sodium for injection)prescriptionHuman PrescriptionUs Worldmeds, LlcMANUFACTURE2014-12-162275050003

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