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FDA NDA · NDA209128

DSUVIA

Sponsor: VERTICAL PHARMS

APPLICATION
NDA209128
TYPE
NDA
ORIGINAL APPROVAL
2018-11-02
LATEST ACTION
2025-12-22
ROUTE
SUBLINGUAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

DSUVIA · ReferenceDiscontinued
SUFENTANIL CITRATE EQ 0.03MG BASE · TABLET · SUBLINGUAL

Approval history

2025-12-22Labeling · Supplement 8 · standard — Letter ↗AP
2023-12-15Labeling · Supplement 7 · standard — Label ↗AP
2022-04-21REMS · Supplement 5 — Letter ↗AP
2019-10-07Labeling · Supplement 3 · standard — Letter ↗AP
2018-11-02Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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