FDA.reportPublic FDA data

Application 202324

Type
NDA
Sponsor
PF PRISM CV

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INLYTAAXITINIBTABLET;ORAL1MGYesNo
002INLYTAAXITINIBTABLET;ORAL5MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-0145INLYTAaxitinibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0145INLYTAaxitinibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0145INLYTAaxitinibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0145INLYTAaxitinibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0145INLYTAaxitinibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0145INLYTAaxitinibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0151INLYTAaxitinibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0151INLYTAaxitinibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0151INLYTAaxitinibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0151INLYTAaxitinibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0151INLYTAaxitinibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0151INLYTAaxitinibPfizer Laboratories Div Pfizer IncNDACurrent
63539-026INLYTAaxitinibU.S. PharmaceuticalsNDACurrent
63539-026INLYTAaxitinibU.S. PharmaceuticalsNDACurrent
63539-026INLYTAaxitinibU.S. PharmaceuticalsNDACurrent
63539-026INLYTAaxitinibU.S. PharmaceuticalsNDACurrent
63539-044INLYTAaxitinibU.S. PharmaceuticalsNDACurrent
63539-044INLYTAaxitinibU.S. PharmaceuticalsNDACurrent
63539-044INLYTAaxitinibU.S. PharmaceuticalsNDACurrent
63539-044INLYTAaxitinibU.S. PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79135SUPPL 2024-07-22
79107SUPPL 2024-07-17
72196SUPPL2022-09-30
72143SUPPL2022-09-23
63431SUPPL2020-06-08
63425SUPPL2020-06-05
61645SUPPL2020-01-24
61637SUPPL2020-01-24
55201SUPPL2018-08-17
55171SUPPL2018-08-13
19319SUPPL2015-12-29
32233SUPPL2014-12-31
40167SUPPL2014-08-04
10025SUPPL2014-08-04
10024SUPPL2013-09-17
19318SUPPL2013-09-16
43395ORIG2012-02-27
24416ORIG2012-02-27
10023ORIG2012-01-31
19317ORIG2012-01-27