FDA.reportPublic FDA data

Application 019516

Type
NDA
Sponsor
PURDUE PHARMA LP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MS CONTINMORPHINE SULFATETABLET, EXTENDED RELEASE;ORAL30MGYesNo
002MS CONTINMORPHINE SULFATETABLET, EXTENDED RELEASE;ORAL60MGYesNo
003MS CONTINMORPHINE SULFATETABLET, EXTENDED RELEASE;ORAL15MGYesNo
004MS CONTINMORPHINE SULFATETABLET, EXTENDED RELEASE;ORAL100MGYesYes
005MS CONTINMORPHINE SULFATETABLET, EXTENDED RELEASE;ORAL200MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42858-515MS Continmorphine sulfateRhodes Pharmaceuticals L.P.NDACurrent
42858-515MS Continmorphine sulfateRhodes Pharmaceuticals L.P.NDACurrent
42858-515MS Continmorphine sulfateRhodes Pharmaceuticals L.P.NDACurrent
42858-515MS Continmorphine sulfateRhodes Pharmaceuticals L.P.NDACurrent
42858-631MS Continmorphine sulfateRhodes Pharmaceuticals L.P.NDACurrent
42858-631MS Continmorphine sulfateRhodes Pharmaceuticals L.P.NDACurrent
42858-631MS Continmorphine sulfateRhodes Pharmaceuticals L.P.NDACurrent
42858-631MS Continmorphine sulfateRhodes Pharmaceuticals L.P.NDACurrent
42858-760MS Continmorphine sulfateRhodes Pharmaceuticals L.P.NDACurrent
42858-760MS Continmorphine sulfateRhodes Pharmaceuticals L.P.NDACurrent
42858-760MS Continmorphine sulfateRhodes Pharmaceuticals L.P.NDACurrent
42858-760MS Continmorphine sulfateRhodes Pharmaceuticals L.P.NDACurrent
42858-799MS Continmorphine sulfateRhodes Pharmaceuticals L.P.NDACurrent
42858-799MS Continmorphine sulfateRhodes Pharmaceuticals L.P.NDACurrent
42858-799MS Continmorphine sulfateRhodes Pharmaceuticals L.P.NDACurrent
42858-799MS Continmorphine sulfateRhodes Pharmaceuticals L.P.NDACurrent
42858-900MS Continmorphine sulfateRhodes Pharmaceuticals L.P.NDACurrent
42858-900MS Continmorphine sulfateRhodes Pharmaceuticals L.P.NDACurrent
42858-900MS Continmorphine sulfateRhodes Pharmaceuticals L.P.NDACurrent
42858-900MS Continmorphine sulfateRhodes Pharmaceuticals L.P.NDACurrent
59011-260MS Continmorphine sulfatePurdue Pharma LPNDACurrent
59011-261MS Continmorphine sulfatePurdue Pharma LPNDACurrent
59011-262MS Continmorphine sulfatePurdue Pharma LPNDACurrent
59011-263MS Continmorphine sulfatePurdue Pharma LPNDACurrent
59011-264MS Continmorphine sulfatePurdue Pharma LPNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84712SUPPL 2026-01-07
84711SUPPL 2026-01-07
84563SUPPL 2025-12-29
80088SUPPL 2024-11-04
76993SUPPL 2023-12-19
76890SUPPL 2023-12-18
66525SUPPL2021-03-05
66522SUPPL2021-03-05
66521SUPPL2021-03-05
60321SUPPL2019-10-08
60312SUPPL2019-10-08
60311SUPPL2019-10-08
55835SUPPL2018-10-05
55834SUPPL2018-10-05
55651SUPPL2018-09-28
55650SUPPL2018-09-28
48580SUPPL2017-05-31
46395SUPPL2016-12-21
46236SUPPL2016-12-20
45459SUPPL2016-10-04
1359SUPPL2016-04-22
17428SUPPL2015-06-29
33771SUPPL2014-10-30
1357SUPPL2014-10-30
1358SUPPL2014-08-20
17427SUPPL2014-04-17
33770SUPPL2014-04-16
17426SUPPL2013-04-16
33769SUPPL2012-07-13
33768SUPPL2012-07-12
23962ORIG2012-07-11
17425SUPPL2012-07-11
1356SUPPL2012-07-11
33767SUPPL2010-05-17
1355SUPPL2010-05-14
1354SUPPL2007-05-29
1353SUPPL2004-06-09
17424SUPPL2003-08-14