Morphine Extended Release Oral Capsule

Brand(s)
Avinza, Kadian
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Actavis Pharma, Inc. (2014-08-01)
Oldest Current Product
2001-11-07
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
EXTENDED RELEASE ORAL CAPSULE\MORPHINE
FDAOB
ORAL\CAPSULE, EXTENDED RELEASE\MORPHINE SULFATE
SPL Active
ORAL\CAPSULE, COATED, EXTENDED RELEASE\MORPHINE SULFATE
ORAL\CAPSULE, EXTENDED RELEASE\MORPHINE SULFATE
ORAL\CAPSULE\MORPHINE SULFATE
SPL Moiety
ORAL\CAPSULE, COATED, EXTENDED RELEASE\MORPHINE
ORAL\CAPSULE, EXTENDED RELEASE\MORPHINE
ORAL\CAPSULE\MORPHINE

product(s) by strength(s)

morphine sulfate 10 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1469870410KadianNDAActavis Kadian Llc2009-04-07MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0206162cb462d0-f4a5-41b4-b4d5-8b3d8453e0e9

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002283501NDA AUTHORIZED GENERICActavis Elizabeth Llc2011-11-11MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0206166fe62c06-5bab-4fc8-b546-ff015a1fc40c
2008320225ANDAUpsher-Smith Laboratories, Inc.2013-06-30MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA20210497948a8f-7d1b-4614-b11d-e944cf56590b

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1353560047KadianNDALake Erie Medical Dba Quality Care Products Llc2012-02-29MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE469870410NDA020616e625a2d5-6727-426d-a7d1-119a49f82dfc
2548685964KadianNDAPhysicians Total Care, Inc.2008-11-19MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE63857041011NDA0206166c826b0a-ac87-48cc-a780-9a4a2118e8a8

morphine sulfate 100 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1498840838NDAPar Pharmaceutical Companies, Inc.2012-11-09MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0206164598407c-11cc-4f04-8acb-723f97aa16b8
2525440164KadianNDAActavis Pharma, Inc.2009-04-07MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA020616adae46f8-3477-418d-9fd0-322ace413817

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002283507NDA AUTHORIZED GENERICActavis Elizabeth Llc2011-11-11MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0206166fe62c06-5bab-4fc8-b546-ff015a1fc40c
2005913453ANDAWatson Laboratories, Inc.2011-11-10MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA2008120e56601d-1c78-4258-9106-40c19a92cca8
3008320233ANDAUpsher-Smith Laboratories, Inc.2013-06-30MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA20210497948a8f-7d1b-4614-b11d-e944cf56590b
4498840670ANDAPar Pharmaceutical Companies, Inc.2011-11-10MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA200812bcb37ca5-9406-4e5a-bcd4-7e737e403c33

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900740KadianNDAStat Rx Usa Llc2009-04-07MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE469870324NDA020616a6b1858a-e796-4cb0-8a4d-d5c521874e84
2353560052KadianNDALake Erie Medical Dba Quality Care Products Llc2012-02-29MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE469870324NDA020616e625a2d5-6727-426d-a7d1-119a49f82dfc
3548684573KadianNDAPhysicians Total Care, Inc.2008-11-20MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE63857032411NDA0206166c826b0a-ac87-48cc-a780-9a4a2118e8a8

24 hr morphine sulfate 120 mg extended release oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002283093ANDAActavis Elizabeth Llc2014-02-04MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA0790402da87bfa-11fd-43e3-8fef-d16ebeb15680

invalid application product(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1353560339AvinzaNDALake Erie Medical Dba Quality Care Products Llc2011-10-25MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE607930608NDA021260092883c0-687f-4ced-9e2b-a1d7a9579926
2607930608AvinzaNDAPfizer Laboratories Div Pfizer Inc2002-03-202017-01-31MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0212603e361ca5-911a-4216-bac4-67ee47cb0e24

morphine sulfate 130 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1469870329KadianNDAActavis Kadian Llc2012-05-07MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0206162cb462d0-f4a5-41b4-b4d5-8b3d8453e0e9

morphine sulfate 150 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1469870330KadianNDAActavis Kadian Llc2012-05-07MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0206162cb462d0-f4a5-41b4-b4d5-8b3d8453e0e9

morphine sulfate 20 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1469870322KadianNDAActavis Kadian Llc2009-04-07MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0206162cb462d0-f4a5-41b4-b4d5-8b3d8453e0e9
2498840833NDAPar Pharmaceutical Companies, Inc.2012-11-09MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0206164598407c-11cc-4f04-8acb-723f97aa16b8

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002283502NDA AUTHORIZED GENERICActavis Elizabeth Llc2011-11-11MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0206166fe62c06-5bab-4fc8-b546-ff015a1fc40c
2005913449ANDAWatson Laboratories, Inc.2011-11-10MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA2008120e56601d-1c78-4258-9106-40c19a92cca8
3008320226ANDAUpsher-Smith Laboratories, Inc.2013-06-30MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA20210497948a8f-7d1b-4614-b11d-e944cf56590b
4498840665ANDAPar Pharmaceutical Companies, Inc.2011-11-10MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA200812bcb37ca5-9406-4e5a-bcd4-7e737e403c33

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900697KadianNDAStat Rx Usa Llc2009-04-07MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE469870322NDA020616a6b1858a-e796-4cb0-8a4d-d5c521874e84
2353560048KadianNDALake Erie Medical Dba Quality Care Products Llc2011-12-21MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE469870322NDA02061645d52221-5644-4f07-91eb-40faf3f899e6
3548684571KadianNDAPhysicians Total Care, Inc.2001-11-07MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE63857032211NDA0206166c826b0a-ac87-48cc-a780-9a4a2118e8a8
4607600322KadianNDASt Marys Medical Park Pharmacy2010-12-21MORPHINE SULFATEORALCAPSULE469870322NDA02061658159bbc-d862-4a2a-8486-874e0007487b
5636294191KadianNDABryant Ranch Prepack2009-04-07MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE469870322NDA020616f4474706-e0de-5170-05c5-cf6762630ebc

morphine sulfate 200 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1469870377KadianNDAActavis Kadian Llc2009-04-07MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0206162cb462d0-f4a5-41b4-b4d5-8b3d8453e0e9

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002283508NDA AUTHORIZED GENERICActavis Elizabeth Llc2011-11-11MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0206166fe62c06-5bab-4fc8-b546-ff015a1fc40c

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900885KadianNDAStat Rx Usa Llc2009-04-07MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE638570377NDA020616a6b1858a-e796-4cb0-8a4d-d5c521874e84

morphine sulfate 30 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1498840834NDAPar Pharmaceutical Companies, Inc.2012-11-09MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0206164598407c-11cc-4f04-8acb-723f97aa16b8
2525440032KadianNDAActavis Pharma, Inc.2009-04-07MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA020616adae46f8-3477-418d-9fd0-322ace413817

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002283503NDA AUTHORIZED GENERICActavis Elizabeth Llc2011-11-11MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0206166fe62c06-5bab-4fc8-b546-ff015a1fc40c
2005913450ANDAWatson Laboratories, Inc.2011-11-10MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA2008120e56601d-1c78-4258-9106-40c19a92cca8
3008320227ANDAUpsher-Smith Laboratories, Inc.2013-06-30MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA20210497948a8f-7d1b-4614-b11d-e944cf56590b
4498840666ANDAPar Pharmaceutical Companies, Inc.2011-11-10MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA200812bcb37ca5-9406-4e5a-bcd4-7e737e403c33

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900660KadianNDAStat Rx Usa Llc2009-04-07MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE469870325NDA020616a6b1858a-e796-4cb0-8a4d-d5c521874e84
2353560049KadianNDALake Erie Medical Dba Quality Care Products Llc2011-12-21MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE469870325NDA02061645d52221-5644-4f07-91eb-40faf3f899e6
3548684981KadianNDAPhysicians Total Care, Inc.2004-01-16MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE63857032511NDA0206166c826b0a-ac87-48cc-a780-9a4a2118e8a8
4636294694KadianNDABryant Ranch Prepack2009-04-07MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE469870325NDA020616f62a95d3-67dd-4016-9959-7519363d5ae9

24 hr morphine sulfate 30 mg extended release oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002283090ANDAActavis Elizabeth Llc2014-02-04MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA0790402da87bfa-11fd-43e3-8fef-d16ebeb15680

invalid application product(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900594AvinzaNDAStat Rx Usa Llc2002-03-20MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE607930605NDA02126059007321-a6e4-4c98-858e-e824921f6a35
2607930605AvinzaNDAPfizer Laboratories Div Pfizer Inc2002-03-202015-08-31MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0212603e361ca5-911a-4216-bac4-67ee47cb0e24
3636293766AvinzaNDABryant Ranch Prepack2002-03-20MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE607930605NDA021260ec7efdca-42a0-416a-b57c-af24cc43d9f3

morphine sulfate 40 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1469870327KadianNDAActavis Kadian Llc2012-05-07MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0206162cb462d0-f4a5-41b4-b4d5-8b3d8453e0e9

24 hr morphine sulfate 45 mg extended release oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002283116ANDAActavis Elizabeth Llc2014-02-04MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA0790402da87bfa-11fd-43e3-8fef-d16ebeb15680

invalid application product(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1607930603AvinzaNDAPfizer Laboratories Div Pfizer Inc2002-03-202015-11-30MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0212603e361ca5-911a-4216-bac4-67ee47cb0e24

morphine sulfate 50 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1469870323KadianNDAActavis Kadian Llc2009-04-07MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0206162cb462d0-f4a5-41b4-b4d5-8b3d8453e0e9
2498840835NDAPar Pharmaceutical Companies, Inc.2012-11-09MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0206164598407c-11cc-4f04-8acb-723f97aa16b8

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002283504NDA AUTHORIZED GENERICActavis Elizabeth Llc2011-11-11MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0206166fe62c06-5bab-4fc8-b546-ff015a1fc40c
2005913451ANDAWatson Laboratories, Inc.2011-11-10MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA2008120e56601d-1c78-4258-9106-40c19a92cca8
3008320228ANDAUpsher-Smith Laboratories, Inc.2013-06-30MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA20210497948a8f-7d1b-4614-b11d-e944cf56590b
4498840667ANDAPar Pharmaceutical Companies, Inc.2011-11-10MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA200812bcb37ca5-9406-4e5a-bcd4-7e737e403c33

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900606KadianNDAStat Rx Usa Llc2009-04-07MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE469870323NDA020616a6b1858a-e796-4cb0-8a4d-d5c521874e84
2353560050KadianNDALake Erie Medical Dba Quality Care Products Llc2012-02-29MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE469870323NDA020616e625a2d5-6727-426d-a7d1-119a49f82dfc
3548684572KadianNDAPhysicians Total Care, Inc.2001-11-07MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE63857032311NDA0206166c826b0a-ac87-48cc-a780-9a4a2118e8a8

morphine sulfate 60 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1469870326KadianNDAActavis Kadian Llc2009-04-07MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0206162cb462d0-f4a5-41b4-b4d5-8b3d8453e0e9
2498840836NDAPar Pharmaceutical Companies, Inc.2012-11-09MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0206164598407c-11cc-4f04-8acb-723f97aa16b8

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002283505NDA AUTHORIZED GENERICActavis Elizabeth Llc2011-11-11MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0206166fe62c06-5bab-4fc8-b546-ff015a1fc40c
2005913452ANDAWatson Laboratories, Inc.2011-11-10MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA2008120e56601d-1c78-4258-9106-40c19a92cca8
3008320229ANDAUpsher-Smith Laboratories, Inc.2013-06-30MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA20210497948a8f-7d1b-4614-b11d-e944cf56590b
4498840668ANDAPar Pharmaceutical Companies, Inc.2011-11-10MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA200812bcb37ca5-9406-4e5a-bcd4-7e737e403c33

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900598KadianNDAStat Rx Usa Llc2009-04-07MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE469870326NDA020616a6b1858a-e796-4cb0-8a4d-d5c521874e84
2353560051KadianNDALake Erie Medical Dba Quality Care Products Llc2012-02-29MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE469870326NDA020616e625a2d5-6727-426d-a7d1-119a49f82dfc
3548685850KadianNDAPhysicians Total Care, Inc.2008-01-16MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE63857032611NDA0206166c826b0a-ac87-48cc-a780-9a4a2118e8a8
4636294695KadianNDABryant Ranch Prepack2009-04-07MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE469870326NDA020616155e8576-c28d-4ec5-bc03-baeb3e65878b

24 hr morphine sulfate 60 mg extended release oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002283091ANDAActavis Elizabeth Llc2014-02-04MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA0790402da87bfa-11fd-43e3-8fef-d16ebeb15680

invalid application product(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900593AvinzaNDAStat Rx Usa Llc2002-03-20MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE607930606NDA02126059007321-a6e4-4c98-858e-e824921f6a35
2353560118AvinzaNDALake Erie Medical Dba Quality Care Products Llc2011-10-25MORPHINE SULFATEORALCAPSULE, COATED, EXTENDED RELEASE607930606NDA021260092883c0-687f-4ced-9e2b-a1d7a9579926
3607930606AvinzaNDAPfizer Laboratories Div Pfizer Inc2002-03-202017-01-31MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0212603e361ca5-911a-4216-bac4-67ee47cb0e24
4636293764AvinzaNDABryant Ranch Prepack2002-03-20MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE607930606NDA021260d7a23afd-95ea-4eb8-b88c-416c3c12a078

morphine sulfate 70 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1469870328KadianNDAActavis Kadian Llc2012-05-07MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0206162cb462d0-f4a5-41b4-b4d5-8b3d8453e0e9

24 hr morphine sulfate 75 mg extended release oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002283117ANDAActavis Elizabeth Llc2014-02-04MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA0790402da87bfa-11fd-43e3-8fef-d16ebeb15680

invalid application product(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1607930604AvinzaNDAPfizer Laboratories Div Pfizer Inc2002-03-202015-11-30MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0212603e361ca5-911a-4216-bac4-67ee47cb0e24

morphine sulfate 80 mg extended release oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1469870412KadianNDAActavis Kadian Llc2009-04-07MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0206162cb462d0-f4a5-41b4-b4d5-8b3d8453e0e9
2498840837NDAPar Pharmaceutical Companies, Inc.2012-11-09MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0206164598407c-11cc-4f04-8acb-723f97aa16b8

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002283506NDA AUTHORIZED GENERICActavis Elizabeth Llc2011-11-11MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0206166fe62c06-5bab-4fc8-b546-ff015a1fc40c
2005913576ANDAWatson Laboratories, Inc.2011-11-10MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA2008120e56601d-1c78-4258-9106-40c19a92cca8
3008320230ANDAUpsher-Smith Laboratories, Inc.2013-06-30MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA20210497948a8f-7d1b-4614-b11d-e944cf56590b
4498840669ANDAPar Pharmaceutical Companies, Inc.2011-11-10MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA200812bcb37ca5-9406-4e5a-bcd4-7e737e403c33

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900778KadianNDAStat Rx Usa Llc2009-04-07MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE469870412NDA020616a6b1858a-e796-4cb0-8a4d-d5c521874e84
2353560076KadianNDALake Erie Medical Dba Quality Care Products Llc2012-02-29MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE469870412NDA020616e625a2d5-6727-426d-a7d1-119a49f82dfc

24 hr morphine sulfate 90 mg extended release oral capsule

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002283092ANDAActavis Elizabeth Llc2014-02-04MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASEANDA0790402da87bfa-11fd-43e3-8fef-d16ebeb15680

invalid application product(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900597AvinzaNDAStat Rx Usa Llc2002-03-20MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE607930607NDA02126059007321-a6e4-4c98-858e-e824921f6a35
2353560333AvinzaNDALake Erie Medical Dba Quality Care Products Llc2011-10-25MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE607930607NDA021260092883c0-687f-4ced-9e2b-a1d7a9579926
3607930607AvinzaNDAPfizer Laboratories Div Pfizer Inc2002-03-202017-01-31MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASENDA0212603e361ca5-911a-4216-bac4-67ee47cb0e24
4636293767AvinzaNDABryant Ranch Prepack2002-03-20MORPHINE SULFATEORALCAPSULE, EXTENDED RELEASE607930607NDA02126083958c50-93d4-4af1-b742-51fd98e4f883

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA079040MORPHINE SULFATEACTAVIS ELIZABETH LLC2013-01-16ANDA079040_001, ANDA079040_002, ANDA079040_003, ANDA079040_004, ANDA079040_005, ANDA079040_006
2ANDA200812MORPHINE SULFATEPAR PHARMACEUTICAL INC2011-11-10ANDA200812_001, ANDA200812_002, ANDA200812_003, ANDA200812_004, ANDA200812_005, ANDA200812_006
3ANDA202104MORPHINE SULFATEUPSHER SMITH LABORATORIES INC2013-06-03ANDA202104_001, ANDA202104_002, ANDA202104_003, ANDA202104_004, ANDA202104_005, ANDA202104_006, ANDA202104_007
4ANDA202718MORPHINE SULFATETEVA PHARMACEUTICALS USA2014-12-29ANDA202718_001, ANDA202718_002, ANDA202718_003, ANDA202718_004, ANDA202718_005, ANDA202718_006, ANDA202718_007, ANDA202718_008
5NDA020616KADIANACTAVIS LABORATORIES UT INC1996-07-03NDA020616_001, NDA020616_002, NDA020616_003, NDA020616_004, NDA020616_005, NDA020616_006, NDA020616_007, NDA020616_008, NDA020616_009, NDA020616_010, NDA020616_011, NDA020616_012
6NDA021260AVINZATrueKING PHARMACEUTICALS LLC2002-03-20p6066339, SUBSTANCENDA021260_001, NDA021260_002, NDA021260_003, NDA021260_004, NDA021260_005, NDA021260_006

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA079040_001RXMORPHINE SULFATE (30MG)ORALCAPSULE, EXTENDED RELEASEFalse2013-01-16MORPHINE SULFATE
2ANDA079040_002RXMORPHINE SULFATE (45MG)ORALCAPSULE, EXTENDED RELEASEFalse2013-01-16MORPHINE SULFATE
3ANDA079040_003RXMORPHINE SULFATE (60MG)ORALCAPSULE, EXTENDED RELEASEFalse2013-01-16MORPHINE SULFATE
4ANDA079040_004RXMORPHINE SULFATE (75MG)ORALCAPSULE, EXTENDED RELEASEFalse2013-01-16MORPHINE SULFATE
5ANDA079040_005RXMORPHINE SULFATE (90MG)ORALCAPSULE, EXTENDED RELEASEFalse2013-01-16MORPHINE SULFATE
6ANDA079040_006RXMORPHINE SULFATE (120MG)ORALCAPSULE, EXTENDED RELEASETrue2013-01-16MORPHINE SULFATE
7ANDA200812_001RXMORPHINE SULFATE (20MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12011-11-10MORPHINE SULFATE
8ANDA200812_002RXMORPHINE SULFATE (30MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12011-11-10MORPHINE SULFATE
9ANDA200812_003RXMORPHINE SULFATE (50MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12011-11-10MORPHINE SULFATE
10ANDA200812_004RXMORPHINE SULFATE (60MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12011-11-10MORPHINE SULFATE
11ANDA200812_005RXMORPHINE SULFATE (80MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12011-11-10MORPHINE SULFATE
12ANDA200812_006RXMORPHINE SULFATE (100MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12011-11-10MORPHINE SULFATE
13ANDA202104_001RXMORPHINE SULFATE (10MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12013-06-03MORPHINE SULFATE
14ANDA202104_002RXMORPHINE SULFATE (20MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12013-06-03MORPHINE SULFATE
15ANDA202104_003RXMORPHINE SULFATE (30MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12013-06-03MORPHINE SULFATE
16ANDA202104_004RXMORPHINE SULFATE (50MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12013-06-03MORPHINE SULFATE
17ANDA202104_005RXMORPHINE SULFATE (60MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12013-06-03MORPHINE SULFATE
18ANDA202104_006RXMORPHINE SULFATE (80MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12013-06-03MORPHINE SULFATE
19ANDA202104_007RXMORPHINE SULFATE (100MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12013-06-03MORPHINE SULFATE
20ANDA202718_001RXMORPHINE SULFATE (20MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12014-12-29MORPHINE SULFATE
21ANDA202718_002RXMORPHINE SULFATE (30MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12014-12-29MORPHINE SULFATE
22ANDA202718_003RXMORPHINE SULFATE (50MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12014-12-29MORPHINE SULFATE
23ANDA202718_004RXMORPHINE SULFATE (60MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12014-12-29MORPHINE SULFATE
24ANDA202718_005RXMORPHINE SULFATE (80MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12014-12-29MORPHINE SULFATE
25ANDA202718_006RXMORPHINE SULFATE (100MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12014-12-29MORPHINE SULFATE
26ANDA202718_007RXMORPHINE SULFATE (40MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12015-06-03MORPHINE SULFATE
27ANDA202718_008RXMORPHINE SULFATE (70MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12015-06-03MORPHINE SULFATE
28NDA020616_001RXMORPHINE SULFATE (20MG)ORALCAPSULE, EXTENDED RELEASEFalseAB11996-07-03KADIAN
29NDA020616_002RXMORPHINE SULFATE (50MG)ORALCAPSULE, EXTENDED RELEASEFalseAB11996-07-03KADIAN
30NDA020616_003RXMORPHINE SULFATE (100MG)ORALCAPSULE, EXTENDED RELEASETrueAB11996-07-03KADIAN
31NDA020616_004RXMORPHINE SULFATE (30MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12001-03-09KADIAN
32NDA020616_005RXMORPHINE SULFATE (60MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12001-03-09KADIAN
33NDA020616_006RXMORPHINE SULFATE (80MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12006-10-27KADIAN
34NDA020616_007RXMORPHINE SULFATE (200MG)ORALCAPSULE, EXTENDED RELEASETrueAB12007-02-27KADIAN
35NDA020616_008RXMORPHINE SULFATE (10MG)ORALCAPSULE, EXTENDED RELEASETrueAB12007-04-20KADIAN
36NDA020616_009RXMORPHINE SULFATE (40MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12012-07-09KADIAN
37NDA020616_010RXMORPHINE SULFATE (70MG)ORALCAPSULE, EXTENDED RELEASEFalseAB12012-07-09KADIAN
38NDA020616_011RXMORPHINE SULFATE (130MG)ORALCAPSULE, EXTENDED RELEASEFalse2012-07-09KADIAN
39NDA020616_012RXMORPHINE SULFATE (150MG)ORALCAPSULE, EXTENDED RELEASEFalse2012-07-09KADIAN
40NDA021260_001discontinuedMORPHINE SULFATE (30MG)ORALCAPSULE, EXTENDED RELEASEFalse2002-03-20AVINZA
41NDA021260_002discontinuedMORPHINE SULFATE (60MG)ORALCAPSULE, EXTENDED RELEASEFalse2002-03-20AVINZA
42NDA021260_003discontinuedMORPHINE SULFATE (90MG)ORALCAPSULE, EXTENDED RELEASEFalse2002-03-20AVINZA
43NDA021260_004discontinuedMORPHINE SULFATE (120MG)ORALCAPSULE, EXTENDED RELEASEFalse2002-03-20AVINZA
44NDA021260_005discontinuedMORPHINE SULFATE (45MG)ORALCAPSULE, EXTENDED RELEASEFalse2008-12-18AVINZA
45NDA021260_006discontinuedMORPHINE SULFATE (75MG)ORALCAPSULE, EXTENDED RELEASEFalse2008-12-18AVINZA

patent(s)

#idexpiration dateapplication(s)
1p6066339 (view patent)2017-11-25NDA021260

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1092883c0-687f-4ced-9e2b-a1d7a9579926 (view SPL)AVINZA C II(morphine sulfate extended-release capsules)30 mg, 45 mg, 60 mg, 75 mg, 90 mg, 120 mg Rx OnlyprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrelabel, repack2011-11-163187353560118, 353560333, 353560339
20e56601d-1c78-4258-9106-40c19a92cca8 (view SPL)Morphine Sulfate Extended-release Capsules, USP Revised: May 2011 CII Rx only198528prescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2011-11-146005913449, 005913450, 005913451, 005913452, 005913453, 005913576
3155e8576-c28d-4ec5-bc03-baeb3e65878b (view SPL)KADIAN (morphine sulfate) Extended-Release Capsules, for oral use, CII These highlights do not include all the information needed to use Kadian safely and effectively. See full prescribing information for Kadian. Kadian (morphine sulfate) CAPSULE, EXTENDED RELEASE for ORAL use.Initial U.S. Approval: 1941prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-181000636294695
42cb462d0-f4a5-41b4-b4d5-8b3d8453e0e9 (view SPL)KADIAN (morphine sulfate) Extended-Release Capsules, for oral use, CIIThese highlights do not include all the information needed to use KADIAN safely and effectively. See full prescribing information for KADIAN. KADIAN (morphine sulfate) extended-release capsules,for oral use, CII Initial U.S. Approval: 1941prescriptionHuman PrescriptionActavis Kadian Llc2014-04-309469870322, 469870323, 469870326, 469870327, 469870328, 469870329, 469870330, 469870377, 469870410, 469870412, 469870324, 469870325
52da87bfa-11fd-43e3-8fef-d16ebeb15680 (view SPL)These highlights do not include all the information needed to use morphine sulfate extended-release capsules safely and effectively. See full prescribing information for morphine sulfate extended-release capsules . MORPHINE SULFATE extended-release capsules, USP, for oral use CII (Once Daily) Initial U.S. Approval: 1941prescriptionHuman PrescriptionActavis Elizabeth LlcANALYSIS, LABEL, MANUFACTURE, PACK2015-02-2718002283090, 002283091, 002283092, 002283093, 002283116, 002283117
63e361ca5-911a-4216-bac4-67ee47cb0e24 (view SPL)These highlights do not include all the information needed to use AVINZA safely and effectively. See full prescribing information for AVINZA. AVINZA (morphine sulfate) extended-release capsules, for oral use, CIIInitial U.S. Approval: 1941prescriptionHuman PrescriptionPfizer Laboratories Div Pfizer Inc2015-11-0310607930603, 607930604, 607930605, 607930606, 607930607, 607930608
74598407c-11cc-4f04-8acb-723f97aa16b8 (view SPL)These highlights do not include all the information needed to use Morphine Sulfate Extended-Release Capsules, USP safely and effectively. See full prescribing information for Morphine Sulfate Extended-release Capsules, USP. Morphine Sulfate Extended-release Capsules, USP, for oral use, CII Initial U.S. Approval: 1941prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.MANUFACTURE2014-04-013498840833, 498840834, 498840835, 498840836, 498840837, 498840838
845d52221-5644-4f07-91eb-40faf3f899e6 (view SPL)prescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-02-083413353560048, 353560049
958159bbc-d862-4a2a-8486-874e0007487b (view SPL)Kadian ERprescriptionHuman PrescriptionSt Marys Medical Park Pharmacymanufacture, relabel, repack2012-08-103607600322
1059007321-a6e4-4c98-858e-e824921f6a35 (view SPL)AVINZA C II(morphine sulfate extended-release capsules)30 mg, 45 mg, 60 mg, 75 mg, 90 mg, 120 mg Rx OnlyprescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2011-09-221165900593, 165900594, 165900597
116c826b0a-ac87-48cc-a780-9a4a2118e8a8 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2010-06-111548684571, 548684572, 548684573, 548684981, 548685850, 548685964
126fe62c06-5bab-4fc8-b546-ff015a1fc40c (view SPL)Morphine Sulfate Extended-Release Capsules, USP for oral use, CIIThese highlights do not include all the information needed to use Morphine sulfate safely and effectively. See full prescribing information for Morphine sulfate. Morphine sulfate (Morphine sulfate) CAPSULE, EXTENDED RELEASE for ORAL use.Initial U.S. Approval: 1941prescriptionHuman PrescriptionActavis Elizabeth Llc2014-04-167002283501, 002283502, 002283503, 002283504, 002283505, 002283506, 002283507, 002283508
1383958c50-93d4-4af1-b742-51fd98e4f883 (view SPL)These highlights do not include all the information needed to use AVINZA safely and effectively. See full prescribing information for AVINZA. AVINZA (morphine sulfate) extended-release capsules, for oral use, CII Initial U.S. Approval: 1941prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2012-10-231000636293767
1497948a8f-7d1b-4614-b11d-e944cf56590b (view SPL)MORPHINE Sulfate Extended-release Capsules, for oral use, CII These highlights do not include all the information needed to use MORPHINE Sulfate Extended-release Capsules safely and effectively. See full prescribing information for MORPHINE Sulfate Extended-release Capsules. MORPHINE Sulfate Extended-release Capsules, for oral use, CII Initial U.S. Approval: 1941prescriptionHuman PrescriptionUpsher-Smith Laboratories, Inc.ANALYSIS, MANUFACTURE, PACK2015-07-0710008320225, 008320226, 008320227, 008320228, 008320229, 008320230, 008320233
15a6b1858a-e796-4cb0-8a4d-d5c521874e84 (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llcrelabel, repack2011-06-151165900598, 165900606, 165900660, 165900697, 165900740, 165900778, 165900885
16adae46f8-3477-418d-9fd0-322ace413817 (view SPL)These highlights do not include all the information needed to use KADIAN safely and effectively. See full prescribing information for KADIAN. KADIAN (morphine sulfate) extended-release capsules,for oral use, CII Initial U.S. Approval: 1941prescriptionHuman PrescriptionActavis Pharma, Inc.2014-08-012525440032, 525440164, 525440011, 525440039, 525440052, 525440063, 525440211, 525440220, 525440896
17bcb37ca5-9406-4e5a-bcd4-7e737e403c33 (view SPL)Morphine Sulfate Extended-release Capsules, USP Revised: May 2011 CII Rx only198528prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-02-192498840665, 498840666, 498840667, 498840668, 498840669, 498840670
18d7a23afd-95ea-4eb8-b88c-416c3c12a078 (view SPL)These highlights do not include all the information needed to use AVINZA safely and effectively. See full prescribing information for AVINZA. AVINZA (morphine sulfate) extended-release capsules, for oral use, CII Initial U.S. Approval: 1941prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2012-10-231000636293764
19e625a2d5-6727-426d-a7d1-119a49f82dfc (view SPL)KADIAN CapsulesprescriptionHuman PrescriptionLake Erie Medical Dba Quality Care Products Llcrepack2013-02-083612353560047, 353560050, 353560051, 353560052, 353560076
20ec7efdca-42a0-416a-b57c-af24cc43d9f3 (view SPL)These highlights do not include all the information needed to use AVINZA safely and effectively. See full prescribing information for AVINZA. AVINZA (morphine sulfate) extended-release capsules, for oral use, CII Initial U.S. Approval: 1941prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2012-10-231000636293766
21f4474706-e0de-5170-05c5-cf6762630ebc (view SPL)KADIANprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2009-04-073636294191
22f62a95d3-67dd-4016-9959-7519363d5ae9 (view SPL)KADIAN (morphine sulfate) Extended-Release Capsules, for oral use, CII These highlights do not include all the information needed to use Kadian safely and effectively. See full prescribing information for Kadian. Kadian (morphine sulfate) CAPSULE, EXTENDED RELEASE for ORAL use.Initial U.S. Approval: 1941prescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-181000636294694

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