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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207500
Company: ASTELLAS

Summary Review

Products on NDA 207500

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CRESEMBA	ISAVUCONAZONIUM SULFATE	186MG	CAPSULE;ORAL	Prescription	None	Yes	Yes
CRESEMBA	ISAVUCONAZONIUM SULFATE	74.5MG	CAPSULE;ORAL	Prescription	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207500

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/06/2015	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207500Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207500Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207500Orig1207501Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207500Orig1207501Orig1s000Lbl.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/08/2023	SUPPL-15	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207500s015,207501s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/207500Orig1s015; 207501Orig1s013ltr.pdf
11/22/2022	SUPPL-13	Manufacturing (CMC)-Manufacturing Process	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/207500Orig1s013.pdf
02/17/2022	SUPPL-11	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207500s011,207501s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/207500Orig1s011; 207501Orig1s009ltr.pdf
12/09/2021	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207500s010,207501s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207500Orig1s010;207501Orig1s008ltr.pdf
04/22/2021	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207500s008,207501s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207500Orig1s008; 207501Orig1s007ltr.pdf
05/18/2021	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207500s006,207501s005lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207500Orig1s006;%20207501Orig1s005ltr.pdf
12/09/2019	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207500s005,207501s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207500Orig1s005,207501Orig1s004ltr.pdf
01/05/2016	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
04/03/2015	SUPPL-1	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207500s001,207501s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207500Orig1s001,207501Orig1s001ltr.pdf

Labels for NDA 207500

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/08/2023	SUPPL-15	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207500s015,207501s013lbl.pdf
02/17/2022	SUPPL-11	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207500s011,207501s009lbl.pdf
02/17/2022	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207500s011,207501s009lbl.pdf
12/09/2021	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207500s010,207501s008lbl.pdf
05/18/2021	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207500s006,207501s005lbledt.pdf
04/22/2021	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207500s008,207501s007lbl.pdf
12/09/2019	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207500s005,207501s004lbl.pdf
04/03/2015	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207500s001,207501s001lbl.pdf
04/03/2015	SUPPL-1	Labeling-Package Insert	Label (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207500s001,207501s001lbl.pdf
03/06/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207500Orig1s000lbl.pdf

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