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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

CSV Excel Print

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

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

Original Approvals or Tentative Approvals

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Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes
08/07/2020	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY; Orphan	Label (PDF) Letter (PDF) Review

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Supplements

CSV Excel Print

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
02/11/2025	SUPPL-14	Labeling-Package Insert, Labeling-Patient Package Insert	Label (PDF) Letter (PDF)
09/17/2024	SUPPL-13	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)
02/29/2024	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)
10/03/2023	SUPPL-11	Efficacy-Labeling Change With Clinical Data	Letter (PDF)	Label is not available on this site.
03/24/2023	SUPPL-8	Manufacturing (CMC)-Facility	Label (PDF) Letter (PDF)
09/21/2022	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)
05/27/2022	SUPPL-5	Efficacy-New Patient Population	Label (PDF) Letter (PDF)
05/27/2022	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)
04/30/2021	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)

Showing 1 to 9 of 9 entries

Labels for NDA 213535

CSV Excel Print

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note
02/11/2025	SUPPL-14	Labeling-Package Insert	Label (PDF)
02/11/2025	SUPPL-14	Labeling-Patient Package Insert	Label (PDF)
09/17/2024	SUPPL-13	Efficacy-Labeling Change With Clinical Data	Label (PDF)
02/29/2024	SUPPL-12	Labeling-Package Insert	Label (PDF)
03/24/2023	SUPPL-8	Manufacturing (CMC)-Facility	Label (PDF)
09/21/2022	SUPPL-6	Labeling-Package Insert	Label (PDF)
05/27/2022	SUPPL-5	Efficacy-New Patient Population	Label (PDF)
05/27/2022	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)
04/30/2021	SUPPL-1	Labeling-Package Insert	Label (PDF)
08/07/2020	ORIG-1	Approval	Label (PDF)

Showing 1 to 10 of 10 entries

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