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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209128
Company: VERTICAL PHARMS

REMS

Products on NDA 209128

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DSUVIA	SUFENTANIL CITRATE	EQ 0.03MG BASE	TABLET;SUBLINGUAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209128

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/02/2018	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209128s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209128Orig1s000Ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209128Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209128s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209128Orig1s007ltr.pdf
04/21/2022	SUPPL-5	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209128Orig1s005ltr.pdf
10/07/2019	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209128s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209128Orig1s003ltr.pdf

Labels for NDA 209128

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209128s007lbl.pdf
10/07/2019	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209128s003lbl.pdf
11/02/2018	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209128s000lbl.pdf

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