FDA.reportPublic FDA data

Application 211288

Type
NDA
Sponsor
PFIZER INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIZIMPRODACOMITINIBTABLET;ORAL15MGYesNo
002VIZIMPRODACOMITINIBTABLET;ORAL30MGYesNo
003VIZIMPRODACOMITINIBTABLET;ORAL45MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-0197VizimprodacomitinibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0197VizimprodacomitinibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0197VizimprodacomitinibPfizer Laboratories Div Pfizer IncNDACurrent
0069-1198VizimprodacomitinibPfizer Laboratories Div Pfizer IncNDACurrent
0069-1198VizimprodacomitinibPfizer Laboratories Div Pfizer IncNDACurrent
0069-1198VizimprodacomitinibPfizer Laboratories Div Pfizer IncNDACurrent
0069-2299VizimprodacomitinibPfizer Laboratories Div Pfizer IncNDACurrent
0069-2299VizimprodacomitinibPfizer Laboratories Div Pfizer IncNDACurrent
0069-2299VizimprodacomitinibPfizer Laboratories Div Pfizer IncNDACurrent
63539-197VizimprodacomitinibU.S. PharmaceuticalsNDACurrent
63539-197VizimprodacomitinibU.S. PharmaceuticalsNDACurrent
63539-197VizimprodacomitinibU.S. PharmaceuticalsNDACurrent
63539-197VizimprodacomitinibU.S. PharmaceuticalsNDACurrent
63539-197VizimprodacomitinibU.S. PharmaceuticalsNDACurrent
63539-197VizimprodacomitinibU.S. PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65735SUPPL2020-12-23
65681SUPPL2020-12-22
56168ORIG2018-10-30
55640ORIG2018-09-27
55639ORIG2018-09-27