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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 211635
Company: NEURELIS INC

Medication Guide

Products on NDA 211635

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VALTOCO	DIAZEPAM	5MG/SPRAY	SPRAY;NASAL	Prescription	None	Yes	No
VALTOCO	DIAZEPAM	7.5MG/SPRAY	SPRAY;NASAL	Prescription	None	Yes	No
VALTOCO	DIAZEPAM	10MG/SPRAY	SPRAY;NASAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 211635

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/10/2020	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211635s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/211635Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/211635Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/14/2025	SUPPL-12	Manufacturing (CMC)-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211635Orig1s012corrected_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211635Orig1s012corrected_ltr.pdf
04/15/2025	SUPPL-10	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211635s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211635Orig1s010ltr.pdf
01/13/2023	SUPPL-8	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211635s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211635Orig1s008ltr.pdf
02/04/2022	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211635s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211635Orig1s007ltr.pdf
02/05/2021	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211635s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211635Orig1s003ltr.pdf

Labels for NDA 211635

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/14/2025	SUPPL-12	Manufacturing (CMC)-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211635Orig1s012corrected_lbl.pdf
04/15/2025	SUPPL-10	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211635s010lbl.pdf
01/13/2023	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211635s008lbl.pdf
01/13/2023	SUPPL-8	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211635s008lbl.pdf
02/04/2022	SUPPL-7	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211635s007lbl.pdf
02/04/2022	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211635s007lbl.pdf
02/05/2021	SUPPL-3	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211635s003lbl.pdf
02/05/2021	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/211635s003lbl.pdf
01/10/2020	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211635s000lbl.pdf

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