methylnaltrexone Prefilled Syringe

Brand(s)
Relistor
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Salix Pharmaceuticals, Inc. (2015-04-21)
Oldest Current Product
2012-02-01
License(s)
NDA
RxNORM
PREFILLED SYRINGE\METHYLNALTREXONE
FDAOB
SUBCUTANEOUS\INJECTION\METHYLNALTREXONE BROMIDE
SUBCUTANEOUS\SOLUTION\METHYLNALTREXONE BROMIDE
SPL Active
SUBCUTANEOUS\INJECTION, SOLUTION\METHYLNALTREXONE BROMIDE
SPL Moiety
SUBCUTANEOUS\INJECTION, SOLUTION\METHYLNALTREXONE

product(s) by strength(s)

0.4 ml methylnaltrexone bromide 20 mg/ml prefilled syringe

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1656490552RelistorNDASalix Pharmaceuticals, Inc.2012-02-01METHYLNALTREXONE BROMIDESUBCUTANEOUSINJECTION, SOLUTIONNDA021964c488fb7c-0a5b-487c-b452-996809d1cb99

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA021964RELISTORSALIX PHARMACEUTICALS INC2008-04-24p8247425, TREATMENT OF OPIOID-INDUCED CONSTIPATION
p6559158, TREATMENT OF OPIOID-INDUCED CONSTIPATION
p8822490, TREATMENT OF OPIOID-INDUCED CONSTIPATION, SUBSTANCE
p8420663, TREATMENT OF OPIOID-INDUCED CONSTIPATION
p8552025, SUBSTANCE
NDA021964_001, NDA021964_002, NDA021964_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021964_001RXMETHYLNALTREXONE BROMIDE (12MG/0.6ML)SUBCUTANEOUSSOLUTIONTrue2008-04-24RELISTOR
2NDA021964_002RXMETHYLNALTREXONE BROMIDE (8MG/0.4ML)SUBCUTANEOUSINJECTIONFalse2010-09-27RELISTOR
3NDA021964_003RXMETHYLNALTREXONE BROMIDE (12MG/0.6ML)SUBCUTANEOUSINJECTIONTrue2008-04-24RELISTOR

patent(s)

#idexpiration dateapplication(s)
1p6559158 (view patent)2017-11-03NDA021964
2p8247425 (view patent)2030-12-31NDA021964
3p8420663 (view patent)2029-09-30NDA021964
4p8552025 (view patent)2024-04-08NDA021964
5p8822490 (view patent)2029-09-30NDA021964

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1c488fb7c-0a5b-487c-b452-996809d1cb99 (view SPL)These highlights do not include all the information needed to use RELISTOR safely and effectively. See full prescribing information for RELISTOR. RELISTOR (methylnaltrexone bromide) Subcutaneous InjectionInitial U.S. Approval: 2008prescriptionHuman PrescriptionSalix Pharmaceuticals, Inc.2015-04-2142656490552, 656490551, 656490553

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