FDA.reportPublic FDA data

Application 207103

Type
NDA
Sponsor
PFIZER INC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-0187IbrancepalbociclibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0187IbrancepalbociclibPfizer Laboratories Div PNDACurrent
0069-0187IbrancepalbociclibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0187IbrancepalbociclibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0187IbrancepalbociclibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0188IbrancepalbociclibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0188IbrancepalbociclibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0188IbrancepalbociclibPfizer Laboratories Div PNDACurrent
0069-0188IbrancepalbociclibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0188IbrancepalbociclibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0189IbrancepalbociclibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0189IbrancepalbociclibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0189IbrancepalbociclibPfizer Laboratories Div PNDACurrent
0069-0189IbrancepalbociclibPfizer Laboratories Div Pfizer IncNDACurrent
0069-0189IbrancepalbociclibPfizer Laboratories Div Pfizer IncNDACurrent
63539-187IbrancepalbociclibU.S. PharmaceuticalsNDACurrent
63539-187IbrancepalbociclibU.S. PharmaceuticalsNDACurrent
63539-187IbrancepalbociclibU.S. PharmaceuticalsNDACurrent
63539-187IbrancepalbociclibU.S. PharmaceuticalsNDACurrent
63539-187IbrancepalbociclibU.S. PharmaceuticalsNDACurrent
63539-188IbrancepalbociclibU.S. PharmaceuticalsNDACurrent
63539-188IbrancepalbociclibU.S. PharmaceuticalsNDACurrent
63539-188IbrancepalbociclibU.S. PharmaceuticalsNDACurrent
63539-188IbrancepalbociclibU.S. PharmaceuticalsNDACurrent
63539-188IbrancepalbociclibU.S. PharmaceuticalsNDACurrent
63539-189IbrancepalbociclibU.S. PharmaceuticalsNDACurrent
63539-189IbrancepalbociclibU.S. PharmaceuticalsNDACurrent
63539-189IbrancepalbociclibU.S. PharmaceuticalsNDACurrent
63539-189IbrancepalbociclibU.S. PharmaceuticalsNDACurrent
63539-189IbrancepalbociclibU.S. PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83375SUPPL 2025-09-18
83373SUPPL 2025-09-17
82091SUPPL 2025-05-01
81967SUPPL 2025-04-24
81506SUPPL 2025-03-10
81477SUPPL 2025-03-07
80746SUPPL 2024-12-27
80708SUPPL 2024-12-26
75365SUPPL 2023-09-07
75364SUPPL 2023-09-07
75359SUPPL 2023-09-07
75358SUPPL 2023-09-07
72880SUPPL2022-12-14
72877SUPPL2022-12-14
60747SUPPL2019-10-31
59977SUPPL2019-10-28
59978SUPPL2019-09-11
59956SUPPL2019-09-10
59955SUPPL2019-09-10
59618SUPPL2019-08-07
58221SUPPL2019-04-05
58218SUPPL2019-04-04
57776SUPPL2019-02-22
57706SUPPL2019-02-20
52658SUPPL2018-02-15
52535SUPPL2018-02-09
52495SUPPL2018-02-07
47847SUPPL2017-04-03
47817SUPPL2017-04-03
10612SUPPL2016-02-22
19957SUPPL2016-02-19
44956ORIG2015-03-13
23031ORIG2015-03-13
32845ORIG2015-02-04
40583ORIG2015-02-03