Morphine Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Roxane Laboratories, Inc (2014-11-07)
Oldest Current Product
2008-01-07
License(s)
NDA
RxNORM
ORAL TABLET\MORPHINE
FDAOB
ORAL\TABLET\MORPHINE SULFATE
SPL Active
ORAL\TABLET\MORPHINE SULFATE
SPL Moiety
ORAL\TABLET\MORPHINE

product(s) by strength(s)

morphine sulfate 15 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540235NDARoxane Laboratories, Inc2008-03-17MORPHINE SULFATEORALTABLETNDA0222073c847554-3b4b-4d24-a145-2ef7e9b83699

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1425490602NDAStat Rx Usa Llc2008-03-17MORPHINE SULFATEORALTABLET000540235NDA022207ca2e2b04-c12c-4957-a93e-f8bbe554a8be
2499990848NDALake Erie Medical Dba Quality Care Products Llc2012-03-19MORPHINE SULFATEORALTABLET000540235NDA022207135f85e2-f000-4ef1-98a5-9bf0ab55d2c0
3529590138NDAH.J. Harkins Company, Inc.2008-03-17MORPHINE SULFATEORALTABLET000540235NDA022207d4286d3c-7226-47a6-9fbc-e67e60e46286
4548683191NDAPhysicians Total Care, Inc.2008-01-07MORPHINE SULFATEORALTABLET000540235NDA022207680a996c-08a5-4cdb-b7bd-0ada5d8c7adf
5636294175NDABryant Ranch Prepack2008-03-17MORPHINE SULFATEORALTABLET000540235NDA0222073f3a870e-f325-475b-8453-fe3d1bb8f54a

morphine sulfate 30 mg oral tablet

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540236NDARoxane Laboratories, Inc2008-03-17MORPHINE SULFATEORALTABLETNDA0222073c847554-3b4b-4d24-a145-2ef7e9b83699

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1425490659NDAStat Rx Usa Llc2008-03-17MORPHINE SULFATEORALTABLET000540236NDA022207ca2e2b04-c12c-4957-a93e-f8bbe554a8be
2499990849NDALake Erie Medical Dba Quality Care Products Llc2011-12-13MORPHINE SULFATEORALTABLET000540236NDA022207d9a4179d-b21d-4921-be29-089ecfcb6e6a
3529590182NDAH.J. Harkins Company, Inc.2008-03-17MORPHINE SULFATEORALTABLET000540236NDA022207d4286d3c-7226-47a6-9fbc-e67e60e46286
4548684973NDAPhysicians Total Care, Inc.2009-05-29MORPHINE SULFATEORALTABLET000540236NDA022207680a996c-08a5-4cdb-b7bd-0ada5d8c7adf
5636293789NDABryant Ranch Prepack2008-03-17MORPHINE SULFATEORALTABLET000540236NDA022207408eda31-0188-4f1d-96b9-8224dfe1bbc7
6663360502NDADispensing Solutions, Inc.2008-03-17MORPHINE SULFATEORALTABLET000540236NDA02220767b3273e-af71-4dac-8e49-8bc134d4c591

application(s)

#idtitleapplicantapprovedapproved drug
1NDA022207MORPHINE SULFATEROXANE LABORATORIES INC2008-03-17NDA022207_001, NDA022207_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022207_001RXMORPHINE SULFATE (15MG)ORALTABLETFalse2008-03-17MORPHINE SULFATE
2NDA022207_002RXMORPHINE SULFATE (30MG)ORALTABLETTrue2008-03-17MORPHINE SULFATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1135f85e2-f000-4ef1-98a5-9bf0ab55d2c0 (view SPL)These highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate Tablets, CIIInitial U.S. Approval: 1984prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel, repack2012-03-193674499990848
23c847554-3b4b-4d24-a145-2ef7e9b83699 (view SPL)These highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate Tablets, CIIInitial U.S. Approval: 1984prescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2014-11-074000540235, 000540236
33f3a870e-f325-475b-8453-fe3d1bb8f54a (view SPL)These highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate Tablets, CIIInitial U.S. Approval: 1984prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-175636294175
4408eda31-0188-4f1d-96b9-8224dfe1bbc7 (view SPL)These highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate Tablets, CIIInitial U.S. Approval: 1984prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-171004636293789
567b3273e-af71-4dac-8e49-8bc134d4c591 (view SPL)These highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate Tablets, CIIInitial U.S. Approval: 1984prescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2013-04-081663360502
6680a996c-08a5-4cdb-b7bd-0ada5d8c7adf (view SPL)These highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate Tablets, CIIInitial U.S. Approval: 1984prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-01-117548683191, 548684973
7ca2e2b04-c12c-4957-a93e-f8bbe554a8be (view SPL)These highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate Tablets, CIIInitial U.S. Approval: 1984prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2012-04-232425490602, 425490659
8d4286d3c-7226-47a6-9fbc-e67e60e46286 (view SPL)These highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate Tablets, CIIInitial U.S. Approval: 1984prescriptionHuman PrescriptionH.J. Harkins Company, Inc.API MANUFACTURE, MANUFACTURE2011-12-292529590138, 529590182
9d9a4179d-b21d-4921-be29-089ecfcb6e6a (view SPL)These highlights do not include all the information needed to use Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Tablets. Morphine Sulfate Tablets, CIIInitial U.S. Approval: 1984prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products LlcMANUFACTURE, relabel, repack2011-12-133372499990849

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