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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204958
Company: CHIESI

Summary Review

Products on NDA 204958

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KENGREAL	CANGRELOR	50MG/VIAL	POWDER;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204958

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/22/2015	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204958Orig1s000Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204958Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/204958Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/204958Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/26/2023	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204958Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204958Orig1s003ltr.pdf
10/23/2019	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204958s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/204958Orig1s002ltr.pdf
03/02/2016	SUPPL-1	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204958Orig1s001lbl.pdf

Labels for NDA 204958

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/26/2023	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204958Orig1s003lbl.pdf
10/23/2019	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/204958s002lbl.pdf
03/02/2016	SUPPL-1	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204958Orig1s001lbl.pdf
06/22/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204958Orig1s000Lbl.pdf

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