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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211155
Company: SECURA

Medication Guide

REMS

Products on NDA 211155

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COPIKTRA	DUVELISIB	15MG	CAPSULE;ORAL	Prescription	None	Yes	No
COPIKTRA	DUVELISIB	25MG	CAPSULE;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211155

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/24/2018	ORIG-2	Approval	Efficacy	PRIORITY; Orphan	Letter (PDF) Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211155Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211155Orig1Orig2s000TOC.cfm
09/24/2018	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211155s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/211155Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/211155Orig1Orig2s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/02/2022	SUPPL-6	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211155Orig1s006ltr.pdf
12/17/2021	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211155s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211155Orig1s005ltr.pdf
09/22/2021	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211155s003lbl.pdf
09/26/2019	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211155s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/211155Orig1s001ltr.pdf

Labels for NDA 211155

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/17/2021	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211155s005lbl.pdf
09/22/2021	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211155s003lbl.pdf
09/26/2019	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/211155s001lbl.pdf
09/24/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211155s000lbl.pdf

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