Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 207103
Company: PFIZER INC
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
03/31/2017 SUPPL-4 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207103s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207103Orig1s004ltr.pdf
02/19/2016 SUPPL-2 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207103s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207103Orig1s002ltr.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
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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