Dantrolene Injectable Suspension

Brand(s)
Ryanodex
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Eagle Pharmaceuticals, Inc. (2014-08-01)
Oldest Current Product
2014-07-23
License(s)
NDA
RxNORM
INJECTABLE SUSPENSION\DANTROLENE
FDAOB
INTRAVENOUS\FOR SUSPENSION\DANTROLENE SODIUM
SPL Active
INTRAVENOUS\INJECTION, SUSPENSION\DANTROLENE SODIUM
SPL Moiety
INTRAVENOUS\INJECTION, SUSPENSION\DANTROLENE

product(s) by strength(s)

dantrolene sodium 50 mg/ml injectable suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1423670540RyanodexNDAEagle Pharmaceuticals, Inc.2014-07-23DANTROLENE SODIUMINTRAVENOUSINJECTION, SUSPENSIONNDA2055798f7b3ac0-604d-4c78-b545-5e0f8ea3d698

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA205579RYANODEXEAGLE PHARMACEUTICALS INC2014-07-22p8685460, FOR USE IN THE TREATMENT OF MALIGNANT HYPERTHERMIA IN CONJUNCTION WITH APPROPRIATE SUPPORTIVE MEASURES AND FOR THE PREVENTION OF MALIGNANT HYPERTHERMIA IN PATIENTS AT HIGH RISK.
p7758890, SUBSTANCE
p8604072, SUBSTANCE
p8110225, SUBSTANCE
ORPHAN DRUG EXCLUSIVITY [2021-07-22]NDA205579_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205579_001RXDANTROLENE SODIUM (250MG/VIAL)INTRAVENOUSFOR SUSPENSIONFalse2014-07-22RYANODEX

patent(s)

#idexpiration dateapplication(s)
1p7758890 (view patent)2025-07-01NDA205579
2p8110225 (view patent)2022-12-24NDA205579
3p8604072 (view patent)2022-12-24NDA205579
4p8685460 (view patent)2023-02-15NDA205579

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
18f7b3ac0-604d-4c78-b545-5e0f8ea3d698 (view SPL)These highlights do not include all the information needed to use RYANODEX safely and effectively. See full prescribing information for RYANODEX. RYANODEX (dantrolene sodium) for injectable suspension, for intravenous use. Initial U.S. Approval: 1974prescriptionHuman PrescriptionEagle Pharmaceuticals, Inc.MANUFACTURE2014-08-012423670540

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