Morphine Oral Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Roxane Laboratories, Inc (2015-08-18)
Oldest Current Product
2005-09-12
License(s)
NDA, ANDA
RxNORM
ORAL SOLUTION\MORPHINE
FDAOB
ORAL\SOLUTION\MORPHINE SULFATE
SPL Active
ORAL\SOLUTION\MORPHINE SULFATE
SPL Moiety
ORAL\SOLUTION\MORPHINE

product(s) by strength(s)

morphine sulfate 2 mg/ml oral solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540237NDARoxane Laboratories, Inc2008-03-17MORPHINE SULFATEORALSOLUTIONNDA02219519a17354-8ae9-48cf-ad52-cc774ca801be

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1278080084ANDATris Pharma Inc2015-09-21MORPHINE SULFATEORALSOLUTIONANDA203518d8598654-94ad-4cfb-81d2-9b68e013a428
2576640358ANDACaraco Pharmaceutical Laboratories, Ltd.2012-01-31MORPHINE SULFATEORALSOLUTIONANDA201011a3c980a1-be71-4f99-bb4c-93486f87cdb6
3666890032ANDAVistapharm Inc.2012-03-01MORPHINE SULFATEORALSOLUTIONANDA2019474a219dac-2007-406e-a7de-e5495c36ac00

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1178560237NDAAtlantic Biologicals Corps2008-03-17MORPHINE SULFATEORALSOLUTION000540237NDA02219512c17cfb-7bcf-4457-b1b9-531d7562493c
2548685413NDAPhysicians Total Care, Inc.2005-09-12MORPHINE SULFATEORALSOLUTION000540237NDA0221959740d1b2-d140-4959-a94b-843d4bf139c2

morphine sulfate 20 mg/ml oral solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540404NDARoxane Laboratories, Inc2011-01-25MORPHINE SULFATEORALSOLUTIONNDA02219519a17354-8ae9-48cf-ad52-cc774ca801be
2000540517NDARoxane Laboratories, Inc2011-01-25MORPHINE SULFATEORALSOLUTIONNDA02219519a17354-8ae9-48cf-ad52-cc774ca801be

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004068003ANDAMallinckrodt, Inc.2011-10-03MORPHINE SULFATEORALSOLUTIONANDA202348242c2512-1d49-486b-a9c3-6905f667799e
2005740153ANDAPaddock Laboratories, Llc2012-08-17MORPHINE SULFATEORALSOLUTIONANDA2015743b3146e9-17bc-4b2e-b84b-25f85e055a35
3278080082ANDATris Pharma Inc2015-09-21MORPHINE SULFATEORALSOLUTIONANDA203518d8598654-94ad-4cfb-81d2-9b68e013a428
4484330200ANDASafecor Health, Llc2013-01-17MORPHINE SULFATEORALSOLUTIONANDA202348d5e29ebe-0e74-4ba7-a16c-e3199cc70c11

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1680940754NDAPrecision Dose Inc.2013-08-16MORPHINE SULFATEORALSOLUTION000540404NDA02219554735ee5-9ab8-4614-805d-12c2ffb19fa0
2680940755NDAPrecision Dose Inc.2014-06-04MORPHINE SULFATEORALSOLUTION000540404NDA0221955e6618a9-f7b1-49a1-b504-60232b466cd1

morphine sulfate 4 mg/ml oral solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000540238NDARoxane Laboratories, Inc2008-03-17MORPHINE SULFATEORALSOLUTIONNDA02219519a17354-8ae9-48cf-ad52-cc774ca801be

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1006031445ANDAQualitest Pharmaceuticals2015-10-30MORPHINE SULFATEORALSOLUTIONANDA2023102be59b81-e86b-4a78-8769-7cd52ac51003
2576640359ANDACaraco Pharmaceutical Laboratories, Ltd.2012-01-31MORPHINE SULFATEORALSOLUTIONANDA201011a3c980a1-be71-4f99-bb4c-93486f87cdb6
3666890033ANDAVistapharm Inc.2012-03-01MORPHINE SULFATEORALSOLUTIONANDA2019474a219dac-2007-406e-a7de-e5495c36ac00

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA201011MORPHINE SULFATESUN PHARMACEUTICAL INDUSTRIES INC2014-02-05ANDA201011_001, ANDA201011_002
2ANDA201574MORPHINE SULFATEPADDOCK LABORATORIES LLC2012-08-06ANDA201574_001
3ANDA201947MORPHINE SULFATEVISTAPHARM INC2012-01-05ANDA201947_001, ANDA201947_002
4ANDA202310MORPHINE SULFATEVINTAGE PHARMACEUTICALS LLC2015-10-30ANDA202310_001
5ANDA202348MORPHINE SULFATEMALLINCKRODT INC2011-07-15ANDA202348_001
6ANDA203518MORPHINE SULFATETRIS PHARMA INC2015-05-12ANDA203518_001, ANDA203518_002
7NDA022195MORPHINE SULFATEROXANE LABORATORIES INC2008-03-17NDA022195_001, NDA022195_002, NDA022195_003
8NDA201517MORPHINE SULFATELANNETT HOLDINGS INC2011-06-23NDA201517_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA201011_001RXMORPHINE SULFATE (10MG/5ML)ORALSOLUTIONFalseAA2014-02-05MORPHINE SULFATE
2ANDA201011_002RXMORPHINE SULFATE (20MG/5ML)ORALSOLUTIONFalseAA2014-02-05MORPHINE SULFATE
3ANDA201574_001RXMORPHINE SULFATE (100MG/5ML)ORALSOLUTIONFalseAA2012-08-06MORPHINE SULFATE
4ANDA201947_001RXMORPHINE SULFATE (10MG/5ML)ORALSOLUTIONFalseAA2012-01-05MORPHINE SULFATE
5ANDA201947_002RXMORPHINE SULFATE (20MG/5ML)ORALSOLUTIONFalseAA2012-01-05MORPHINE SULFATE
6ANDA202310_001RXMORPHINE SULFATE (20MG/5ML)ORALSOLUTIONFalseAA2015-10-30MORPHINE SULFATE
7ANDA202348_001RXMORPHINE SULFATE (100MG/5ML)ORALSOLUTIONFalseAA2011-07-15MORPHINE SULFATE
8ANDA203518_001RXMORPHINE SULFATE (10MG/5ML)ORALSOLUTIONFalseAA2015-05-12MORPHINE SULFATE
9ANDA203518_002RXMORPHINE SULFATE (100MG/5ML)ORALSOLUTIONFalseAA2015-05-12MORPHINE SULFATE
10NDA022195_001RXMORPHINE SULFATE (10MG/5ML)ORALSOLUTIONFalseAA2008-03-17MORPHINE SULFATE
11NDA022195_002RXMORPHINE SULFATE (20MG/5ML)ORALSOLUTIONFalseAA2008-03-17MORPHINE SULFATE
12NDA022195_003RXMORPHINE SULFATE (100MG/5ML)ORALSOLUTIONTrueAA2010-01-25MORPHINE SULFATE
13NDA201517_001RXMORPHINE SULFATE (100MG/5ML)ORALSOLUTIONFalse2011-06-23MORPHINE SULFATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
112c17cfb-7bcf-4457-b1b9-531d7562493c (view SPL)These highlights do not include all the information needed to use Morphine Sulfate Oral Solution safely and effectively. See full prescribing information for Morphine Sulfate Oral Solution. Morphine Sulfate Oral Solution, CII Initial U.S. Approval: 1941prescriptionHuman PrescriptionAtlantic Biologicals CorpsRELABEL, REPACK2015-08-183178560237
219a17354-8ae9-48cf-ad52-cc774ca801be (view SPL)These highlights do not include all the information needed to use Morphine Sulfate Oral Solution safely and effectively. See full prescribing information for Morphine Sulfate Oral Solution.Morphine Sulfate Oral Solution, CII Initial U.S. Approval: 1941prescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2015-08-1814000540237, 000540238, 000540404, 000540517
3242c2512-1d49-486b-a9c3-6905f667799e (view SPL)These highlights do not include all the information needed to use Morphine Sulfate Oral Solution safely and effectively. See full prescribing information for Morphine Sulfate Oral Solution. MORPHINE Sulfate Oral Solution, CIIInitial U.S. Approval: 1941prescriptionHuman PrescriptionMallinckrodt, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2015-05-3110004068003
42be59b81-e86b-4a78-8769-7cd52ac51003 (view SPL)These highlights do not include all the information needed to useMorphine Sulfate Oral Solution safely and effectively. See full prescribing information for Morphine Sulfate Oral Solution. Morphine Sulfate Oral Solution, CII Initial U.S. Approval: 1941prescriptionHuman PrescriptionQualitest PharmaceuticalsMANUFACTURE2013-01-014006031445
53b3146e9-17bc-4b2e-b84b-25f85e055a35 (view SPL)These highlights do not include all the information needed to use Morphine Sulfate Oral Solution safely and effectively. See full prescribing information for Morphine Sulfate Oral Solution.Morphine Sulfate Oral Solution, CII Initial U.S. Approval: 1941prescriptionHuman PrescriptionPaddock Laboratories, Llc2014-02-044005740153
64a219dac-2007-406e-a7de-e5495c36ac00 (view SPL)These highlights do not include all the information needed to use morphine sulfate oral solution safely and effectively. See full prescribing information for morphine sulfate oral solution.Morphine sulfate oral solution, C-IIInitial U.S. Approval: 1984prescriptionHuman PrescriptionVistapharm Inc.ANALYSIS, MANUFACTURE, REPACK2012-02-245666890032, 666890033
74d425667-006b-446d-832c-63040509ad59 (view SPL)These highlights do not include all the information needed to use Morphine Sulfate Oral Solution safely and effectively. See full prescribing information for Morphine Sulfate Oral Solution. Morphine Sulfate Oral Solution, CII Initial U.S. Approval: 1984prescriptionHuman PrescriptionLannett Company, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2013-07-2919005271425
854735ee5-9ab8-4614-805d-12c2ffb19fa0 (view SPL)These highlights do not include all the information needed to use MORPHINE Sulfate Oral Solution safely and effectively. See full prescribing information for MORPHINE Sulfate Oral Solution. MORPHINE Sulfate Oral Solution, CIIInitial U.S. Approval: 1941prescriptionHuman PrescriptionPrecision Dose Inc.2015-11-031680940754
95e6618a9-f7b1-49a1-b504-60232b466cd1 (view SPL)These highlights do not include all the information needed to use MORPHINE Sulfate Oral Solution safely and effectively. See full prescribing information for MORPHINE Sulfate Oral Solution. MORPHINE Sulfate Oral Solution, CII Initial U.S. Approval: 1941prescriptionHuman PrescriptionPrecision Dose Inc.2015-11-041680940755
109740d1b2-d140-4959-a94b-843d4bf139c2 (view SPL)These highlights do not include all the information needed to use Morphine Sulfate Oral Solution and Morphine Sulfate Tablets safely and effectively. See full prescribing information for Morphine Sulfate Oral Solution and Morphine Sulfate Tablets.Initial U.S. Approval: 1984prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2011-02-071548685413
11a3c980a1-be71-4f99-bb4c-93486f87cdb6 (view SPL)These highlights do not include all the information needed to use morphine sulfate oral solution safely and effectively. See full prescribing information for morphine sulfate oral solution. Morphine Sulfate Oral Solution, CIIInitial U.S. Approval: 1941prescriptionHuman PrescriptionCaraco Pharmaceutical Laboratories, Ltd.ANALYSIS, MANUFACTURE, PACK2013-03-073576640358, 576640359
12d5e29ebe-0e74-4ba7-a16c-e3199cc70c11 (view SPL)These highlights do not include all the information needed to use Morphine Sulfate Oral Solution safely and effectively. See full prescribing information for Morphine Sulfate Oral Solution. Morphine Sulfate Oral Solution, CIIInitial U.S. Approval: 1941prescriptionHuman PrescriptionSafecor Health, LlcANALYSIS, API MANUFACTURE, MANUFACTURE2013-01-161484330200
13d8598654-94ad-4cfb-81d2-9b68e013a428 (view SPL)These highlights do not include all the information needed to use Morphine Sulfate Oral Solution safely and effectively. See full prescribing information for Morphine Sulfate Oral Solution CII. MORPHINE sulfate oral solution, for oral use Initial U.S. Approval: 1941prescriptionHuman PrescriptionTris Pharma Inc2015-10-019278080082, 278080084

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