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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212436
Company: PFIZER

Products on NDA 212436

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IBRANCE	PALBOCICLIB	75MG	TABLET;ORAL	Prescription	AB	Yes	No
IBRANCE	PALBOCICLIB	100MG	TABLET;ORAL	Prescription	AB	Yes	No
IBRANCE	PALBOCICLIB	125MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212436

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/01/2019	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212436lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212436Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212436Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/16/2025	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212436s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/207103Orig1s023;212436Orig1s011ltr.pdf
12/20/2024	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212436s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/212436Orig1s010ltr.pdf
03/06/2025	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/207103s021,212436s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/207103Orig1s021,212436Orig1s009ltr.pdf
04/23/2025	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212436s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/207103Orig1s020; 212436Orig1s008ltr.pdf
09/06/2023	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212436s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212436Orig1s005,s006ltr.pdf
09/06/2023	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212436s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212436Orig1s005,s006ltr.pdf
12/13/2022	SUPPL-3	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212436s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/207103Orig1s015;212436Orig1s003ltr.pdf

Labels for NDA 212436

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/16/2025	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212436s011lbl.pdf
04/23/2025	SUPPL-8	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212436s008lbl.pdf
03/06/2025	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/207103s021,212436s009lbl.pdf
12/20/2024	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212436s010lbl.pdf
09/06/2023	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212436s005s006lbl.pdf
09/06/2023	SUPPL-5	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212436s005s006lbl.pdf
12/13/2022	SUPPL-3	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212436s003lbl.pdf
11/01/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212436lbl.pdf

Therapeutic Equivalents for NDA 212436

IBRANCE

TABLET;ORAL; 75MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IBRANCE	PALBOCICLIB	75MG	TABLET;ORAL	Prescription	Yes	AB	212436	PFIZER

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IBRANCE	PALBOCICLIB	100MG	TABLET;ORAL	Prescription	Yes	AB	212436	PFIZER

TABLET;ORAL; 125MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IBRANCE	PALBOCICLIB	125MG	TABLET;ORAL	Prescription	Yes	AB	212436	PFIZER

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