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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 216387
Company: ASTRAZENECA

Products on NDA 216387

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CALQUENCE	ACALABRUTINIB MALEATE	EQ 100MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 216387

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/03/2022	ORIG-2	Approval	Type 3 - New Dosage Form	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216387Orig2s000Correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/216387Orig2s000Correctedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/216387Orig1Orig2s000TOC.cfm
08/03/2022	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan	Label (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216387Orig1s000Correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/216387Orig1Orig2s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/16/2025	SUPPL-5	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216387s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/210259Orig1s011;216387Orig1s005ltr.pdf
06/05/2024	SUPPL-4	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216387s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216387Orig1s004ltr.pdf

Labels for NDA 216387

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/16/2025	SUPPL-5	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216387s005lbl.pdf
06/05/2024	SUPPL-4	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216387s004lbl.pdf
06/05/2024	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216387s004lbl.pdf
08/03/2022	ORIG-2	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216387Orig2s000Correctedlbl.pdf
08/03/2022	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216387Orig1s000Correctedlbl.pdf

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