FDA.reportPublic FDA data

Application 212436

Type
NDA
Sponsor
PFIZER INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBRANCEPALBOCICLIBTABLET;ORAL75MGYesNo
002IBRANCEPALBOCICLIBTABLET;ORAL100MGYesNo
003IBRANCEPALBOCICLIBTABLET;ORAL125MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-0284IbrancepalbociclibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0284IbrancepalbociclibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0284IbrancepalbociclibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0284IbrancepalbociclibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0486IbrancepalbociclibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0486IbrancepalbociclibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0486IbrancepalbociclibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0486IbrancepalbociclibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0688IbrancepalbociclibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0688IbrancepalbociclibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0688IbrancepalbociclibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0688IbrancepalbociclibPfizer Laboratories Div Pfizer IncNDACurrent
63539-284IbrancepalbociclibUS PharmaceuticalsNDACurrent
63539-284IbrancepalbociclibUS PharmaceuticalsNDACurrent
63539-284IbrancepalbociclibU.S. PharmaceuticalsNDACurrent
63539-486IbrancepalbociclibUS PharmaceuticalsNDACurrent
63539-486IbrancepalbociclibUS PharmaceuticalsNDACurrent
63539-486IbrancepalbociclibU.S. PharmaceuticalsNDACurrent
63539-688IbrancepalbociclibUS PharmaceuticalsNDACurrent
63539-688IbrancepalbociclibUS PharmaceuticalsNDACurrent
63539-688IbrancepalbociclibU.S. PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83376SUPPL 2025-09-18
83374SUPPL 2025-09-17
82092SUPPL 2025-05-01
81968SUPPL 2025-04-24
81507SUPPL 2025-03-10
81478SUPPL 2025-03-07
80747SUPPL 2024-12-27
80710SUPPL 2024-12-26
75367SUPPL 2023-09-07
75366SUPPL 2023-09-07
75361SUPPL 2023-09-07
75360SUPPL 2023-09-07
72881SUPPL2022-12-14
72878SUPPL2022-12-14
62443ORIG2020-04-06
60784ORIG2019-11-12
60778ORIG2019-11-04