An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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-Package Insert, Labeling-Container/Carton Labels	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-Package Insert, Labeling-Container/Carton Labels	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-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207500s011,207501s009lbl.pdf
02/17/2022	SUPPL-11	Labeling-Container/Carton Labels	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-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
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
03/06/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207500Orig1s000lbl.pdf

Top