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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207103
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
IBRANCE PALBOCICLIB 75MG CAPSULE;ORAL Prescription None Yes No
IBRANCE PALBOCICLIB 100MG CAPSULE;ORAL Prescription None Yes No
IBRANCE PALBOCICLIB 125MG CAPSULE;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/03/2015 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207103s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207103Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207103Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207103Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/06/2023 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207103s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/207103Orig1s017,s018ltr.pdf
09/06/2023 SUPPL-17 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207103s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/207103Orig1s017,s018ltr.pdf
12/13/2022 SUPPL-15 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207103s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/207103Orig1s015;212436Orig1s003ltr.pdf
09/09/2019 SUPPL-12 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207103Orig1s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207103Orig1s012ltr.pdf
09/09/2019 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207103s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207103Orig1s011ltr.pdf
02/19/2019 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207103s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207103Orig1s010ltr.pdf
04/04/2019 SUPPL-8 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207103s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207103Orig1s008ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/207103Orig1s008.pdf
02/06/2018 SUPPL-7 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207103s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207103Orig1s007ltr.pdf
03/31/2017 SUPPL-4 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207103s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207103Orig1s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/207103Orig1s004.pdf
02/19/2016 SUPPL-2 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207103s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207103Orig1s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/207103Orig1s002.pdf
12/17/2015 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/06/2023 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207103s017s018lbl.pdf
09/06/2023 SUPPL-17 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207103s017s018lbl.pdf
12/13/2022 SUPPL-15 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207103s015lbl.pdf
09/09/2019 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207103Orig1s012lbl.pdf
09/09/2019 SUPPL-12 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207103Orig1s012lbl.pdf
09/09/2019 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207103s011lbl.pdf
04/04/2019 SUPPL-8 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207103s008lbl.pdf
02/19/2019 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207103s010lbl.pdf
02/06/2018 SUPPL-7 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207103s007lbl.pdf
03/31/2017 SUPPL-4 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207103s004lbl.pdf
02/19/2016 SUPPL-2 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207103s002lbl.pdf
02/03/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207103s000lbl.pdf
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