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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 218197
Company: ASTRAZENECA

Products on NDA 218197

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRUQAP	CAPIVASERTIB	160MG	TABLET;ORAL	Prescription	None	Yes	No
TRUQAP	CAPIVASERTIB	200MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 218197

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/16/2023	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/218197s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/218197Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/218197Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/27/2026	SUPPL-5	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/218197Orig1s005ltr.pdf
06/12/2026	SUPPL-4	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218197Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/218197Orig1s004ltr.pdf
11/14/2025	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218197s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218197Orig1s003ltr.pdf
02/13/2025	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218197s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218197Orig1s002ltr.pdf
09/23/2024	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218197s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218197Orig1s001ltr.pdf

Labels for NDA 218197

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/12/2026	SUPPL-4	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218197Orig1s004lbl.pdf
11/14/2025	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218197s003lbl.pdf
02/13/2025	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218197s002lbl.pdf
02/13/2025	SUPPL-2	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218197s002lbl.pdf
09/23/2024	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218197s001lbl.pdf
09/23/2024	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/218197s001lbl.pdf
11/16/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/218197s000lbl.pdf

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