FDA.reportPublic FDA data

Application 203341

Type
NDA
Sponsor
PF PRISM CV

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BOSULIFBOSUTINIB MONOHYDRATETABLET;ORALEQ 100MG BASEYesYes
002BOSULIFBOSUTINIB MONOHYDRATETABLET;ORALEQ 500MG BASEYesNo
003BOSULIFBOSUTINIB MONOHYDRATETABLET;ORALEQ 400MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-0135BOSULIFBosutinib monohydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0135BOSULIFBosutinib monohydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0135BOSULIFBosutinib monohydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0135BOSULIFBosutinib monohydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0135BOSULIFBosutinib monohydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0135BOSULIFBosutinib monohydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0135BOSULIFBosutinib monohydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0135BOSULIFBosutinib monohydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0136BOSULIFBosutinib monohydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0136BOSULIFBosutinib monohydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0136BOSULIFBosutinib monohydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0136BOSULIFBosutinib monohydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0136BOSULIFBosutinib monohydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0136BOSULIFBosutinib monohydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0136BOSULIFBosutinib monohydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0136BOSULIFBosutinib monohydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0193BOSULIFBosutinib monohydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0193BOSULIFBosutinib monohydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0193BOSULIFBosutinib monohydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0193BOSULIFBosutinib monohydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0193BOSULIFBosutinib monohydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0193BOSULIFBosutinib monohydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0193BOSULIFBosutinib monohydratePfizer Laboratories Div Pfizer IncNDACurrent
0069-0193BOSULIFBosutinib monohydratePfizer Laboratories Div Pfizer IncNDACurrent
63539-117BOSULIFBosutinibU.S. PharmaceuticalsNDACurrent
63539-117BOSULIFBosutinib monohydrateU.S. PharmaceuticalsNDACurrent
63539-117BOSULIFBosutinib monohydrateU.S. PharmaceuticalsNDACurrent
63539-193BOSULIFBosutinibU.S. PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85286SUPPL 2026-03-06
85262SUPPL 2026-03-04
80522SUPPL 2024-12-05
80496SUPPL 2024-12-04
75572SUPPL 2023-09-27
75570SUPPL 2023-09-26
74044SUPPL 2023-04-24
74036SUPPL 2023-04-21
67511SUPPL2021-05-17
67489SUPPL2021-05-14
63616SUPPL2020-06-18
63613SUPPL2020-06-18
60530SUPPL2019-10-10
60517SUPPL2019-10-10
59724SUPPL2019-08-15
59705SUPPL2019-08-15
56079SUPPL2018-10-23
56045SUPPL2018-10-19
54001SUPPL2018-05-03
50884SUPPL2017-12-27
50777SUPPL2017-12-19
48050SUPPL2017-04-18
48049SUPPL2017-04-18
48040SUPPL2017-04-14
48039SUPPL2017-04-14
45907SUPPL2016-11-18
45909SUPPL2016-11-17
32414SUPPL2016-04-06
19460SUPPL2016-04-05
19459SUPPL2015-10-06
10199SUPPL2015-09-24
40289SUPPL2015-01-05
32413SUPPL2014-11-28
32412SUPPL2013-10-01
40288SUPPL2013-09-30
24432ORIG2012-09-13
22921ORIG2012-09-13
10198ORIG2012-09-06
19458ORIG2012-09-04