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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 217003
Company: PHARMACYCLICS LLC

Products on NDA 217003

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
IMBRUVICA	IBRUTINIB	70MG/ML	SUSPENSION;ORAL	Prescription	None	Yes	Yes
IMBRUVICA	IBRUTINIB	70MG	CAPSULE;ORAL	Prescription	None	No	No
IMBRUVICA	IBRUTINIB	140MG	CAPSULE;ORAL	Prescription	None	No	No
IMBRUVICA	IBRUTINIB	140MG	TABLET;ORAL	Prescription	None	No	No
IMBRUVICA	IBRUTINIB	230MG	TABLET;ORAL	Prescription	None	No	No
IMBRUVICA	IBRUTINIB	420MG	TABLET;ORAL	Prescription	None	No	No
IMBRUVICA	IBRUTINIB	560MG	TABLET;ORAL	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 217003

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/24/2022	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/217003s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217003Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/217003Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/22/2024	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217003s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217003Orig1s002ltr.pdf

Labels for NDA 217003

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/22/2024	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/217003s002lbl.pdf
08/24/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/217003s000lbl.pdf

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