FDA.reportPublic FDA data

Application 206544

Type
NDA
Sponsor
DAIICHI SANKYO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MORPHABOND ERMORPHINE SULFATETABLET, EXTENDED RELEASE;ORAL15MGYesNo
002MORPHABOND ERMORPHINE SULFATETABLET, EXTENDED RELEASE;ORAL30MGYesNo
003MORPHABOND ERMORPHINE SULFATETABLET, EXTENDED RELEASE;ORAL60MGYesNo
004MORPHABOND ERMORPHINE SULFATETABLET, EXTENDED RELEASE;ORAL100MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65597-301MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent
65597-301MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent
65597-301MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent
65597-301MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent
65597-302MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent
65597-302MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent
65597-302MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent
65597-302MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent
65597-303MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent
65597-303MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent
65597-303MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent
65597-303MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent
65597-304MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent
65597-304MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent
65597-304MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent
65597-304MorphaBondmorphine sulfateDaiichi Sankyo Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60429SUPPL2019-10-09
60428SUPPL2019-10-09
60371SUPPL2019-10-08
57123SUPPL2019-02-04
57092SUPPL2019-01-02
55677SUPPL2018-10-01
55676SUPPL2018-10-01
55543SUPPL2018-09-21
55542SUPPL2018-09-21
54426SUPPL2018-06-04
54424SUPPL2018-06-04
48592SUPPL2017-05-31
46440SUPPL2016-12-21
46439SUPPL2016-12-21
46323SUPPL2016-12-20
46322SUPPL2016-12-20
46066ORIG2016-10-20
46065ORIG2016-10-20
45453SUPPL2016-10-03
10579SUPPL2016-04-22
44601ORIG2015-11-04
24128ORIG2015-10-16
40556ORIG2015-10-09
10578ORIG2015-10-09