FDA.reportPublic FDA data

Application 021611

Type
NDA
Sponsor
ENDO PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OPANAOXYMORPHONE HYDROCHLORIDETABLET;ORAL5MGYesNo
002OPANAOXYMORPHONE HYDROCHLORIDETABLET;ORAL10MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60951-794Oxymorphone HydrochlorideOxymorphone HydrochloridePar PharmaceuticalNDA AUTHORIZED GENERICCurrent
60951-794Oxymorphone HydrochlorideOxymorphone HydrochloridePar PharmaceuticalNDA AUTHORIZED GENERICCurrent
60951-795Oxymorphone HydrochlorideOxymorphone HydrochloridePar PharmaceuticalNDA AUTHORIZED GENERICCurrent
60951-795Oxymorphone HydrochlorideOxymorphone HydrochloridePar PharmaceuticalNDA AUTHORIZED GENERICCurrent
63481-612OPANAOxymorphone HydrochlorideEndo Pharmaceuticals, Inc.NDACurrent
63481-612OPANAOxymorphone HydrochlorideEndo Pharmaceuticals Inc.NDACurrent
63481-612OPANAOxymorphone HydrochlorideEndo Pharmaceuticals Inc.NDACurrent
63481-612OPANAOxymorphone HydrochlorideEndo Pharmaceuticals, Inc.NDACurrent
63481-613OPANAOxymorphone HydrochlorideEndo Pharmaceuticals, Inc.NDACurrent
63481-613OPANAOxymorphone HydrochlorideEndo Pharmaceuticals Inc.NDACurrent
63481-613OPANAOxymorphone HydrochlorideEndo Pharmaceuticals Inc.NDACurrent
63481-613OPANAOxymorphone HydrochlorideEndo Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76234ORIG 2023-11-03
60693SUPPL2019-10-29
60685SUPPL2019-10-28
60684SUPPL2019-10-28
60361SUPPL2019-10-08
60358SUPPL2019-10-08
55991SUPPL2018-10-17
55990SUPPL2018-10-17
55683SUPPL2018-10-01
55682SUPPL2018-10-01
46353SUPPL2016-12-21
46287SUPPL2016-12-20
15873SUPPL2014-05-14
5852SUPPL2012-07-11
5851SUPPL2011-02-10
37337SUPPL2011-02-09
5850SUPPL2010-04-22
42232ORIG2008-10-03
28244SUPPL2006-08-07
37336SUPPL2006-08-04
15872ORIG2006-06-28
5849ORIG2006-06-28
63214SUPPL1900-01-01
63213SUPPL1900-01-01