FDA.reportPublic FDA data

Application 203389

Type
NDA
Sponsor
HORIZON PHARMA USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROCYSBICYSTEAMINE BITARTRATECAPSULE, DELAYED RELEASE;ORALEQ 25MG BASEYesNo
002PROCYSBICYSTEAMINE BITARTRATECAPSULE, DELAYED RELEASE;ORALEQ 75MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
75987-100PROCYSBICysteamine bitartrateHorizon Therapeutics USA, Inc.NDACurrent
75987-100PROCYSBICysteamine bitartrateHorizon Pharma Inc.NDACurrent
75987-100PROCYSBICysteamine bitartrateHorizon Pharma Inc.NDACurrent
75987-100PROCYSBICysteamine bitartrateHorizon Therapeutics USA, Inc.NDACurrent
75987-100PROCYSBICysteamine bitartrateHorizon Therapeutics USA, Inc.NDACurrent
75987-100PROCYSBICysteamine bitartrateHorizon Therapeutics USA, Inc.NDACurrent
75987-100PROCYSBICysteamine bitartrateHorizon Therapeutics USA, Inc.NDACurrent
75987-101PROCYSBICysteamine bitartrateHorizon Therapeutics USA, Inc.NDACurrent
75987-101PROCYSBICysteamine bitartrateHorizon Pharma Inc.NDACurrent
75987-101PROCYSBICysteamine bitartrateHorizon Pharma Inc.NDACurrent
75987-101PROCYSBICysteamine bitartrateHorizon Therapeutics USA, Inc.NDACurrent
75987-101PROCYSBICysteamine bitartrateHorizon Therapeutics USA, Inc.NDACurrent
75987-101PROCYSBICysteamine bitartrateHorizon Therapeutics USA, Inc.NDACurrent
75987-101PROCYSBICysteamine bitartrateHorizon Therapeutics USA, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70165SUPPL2022-02-15
70157SUPPL2022-02-14
63703SUPPL2020-06-25
63698SUPPL2020-06-25
58948SUPPL2019-06-04
58929SUPPL2019-06-03
55076SUPPL2018-08-02
50966SUPPL2017-12-29
49862SUPPL2017-09-26
49857SUPPL2017-09-26
51503SUPPL2015-10-06
10207SUPPL2015-08-18
40293SUPPL2015-08-17
43429ORIG2014-03-06
24433ORIG2014-03-06
51502SUPPL2013-08-19
40292ORIG2013-05-01
10206ORIG2013-05-01
54147SUPPL1900-01-01
54145SUPPL1900-01-01
54143SUPPL1900-01-01
52584ORIG1900-01-01
52583ORIG1900-01-01
52582ORIG1900-01-01