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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 213535
Company: GENENTECH INC

Products on NDA 213535

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EVRYSDI	RISDIPLAM	0.75MG/ML	FOR SOLUTION;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 213535

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/07/2020	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213535s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/213535Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/213535Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/17/2024	SUPPL-13	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213535s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213535Orig1s013ltr.pdf
02/29/2024	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213535s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213535Orig1s012ltr.pdf
10/03/2023	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213535Orig1s011ltr.pdf
03/24/2023	SUPPL-8	Manufacturing (CMC)-Facility	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213535s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213535Orig1s008ltr.pdf
09/21/2022	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213535Orig1s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213535Orig1s006ltr.pdf
05/27/2022	SUPPL-5	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213535s003s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213535Orig1s003, s005ltr.pdf
05/27/2022	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213535s003s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/213535Orig1s003, s005ltr.pdf
04/30/2021	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213535s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/213535Orig1s001ltr.pdf

Labels for NDA 213535

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/17/2024	SUPPL-13	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213535s013lbl.pdf
02/29/2024	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213535s012lbl.pdf
03/24/2023	SUPPL-8	Manufacturing (CMC)-Facility	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213535s008lbl.pdf
09/21/2022	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213535Orig1s006lbl.pdf
05/27/2022	SUPPL-5	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213535s003s005lbl.pdf
05/27/2022	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/213535s003s005lbl.pdf
04/30/2021	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213535s001lbl.pdf
08/07/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213535s000lbl.pdf

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