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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 210259
Company: ASTRAZENECA

Products on NDA 210259

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 210259

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/2017	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/210259s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/210259Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/210259Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/24/2022	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210259s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210259Orig1s009ltr.pdf
11/21/2019	SUPPL-7	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210259s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210259Orig1s006, s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210259Orig1s006, s007.pdf
11/21/2019	SUPPL-6	Efficacy-New Indication	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210259s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210259Orig1s006, s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210259Orig1s006, s007.pdf

Labels for NDA 210259

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/24/2022	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210259s009lbl.pdf
11/21/2019	SUPPL-7	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210259s006s007lbl.pdf
11/21/2019	SUPPL-6	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210259s006s007lbl.pdf
10/31/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/210259s000lbl.pdf

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