← FDA DRUG APPROVALS

FDA NDA · NDA021038

PRECEDEX

dexmedetomidine hydrochloride

Sponsor: HOSPIRA

APPLICATION
NDA021038
TYPE
NDA
ORIGINAL APPROVAL
1999-12-17
LATEST ACTION
2026-05-01
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

PRECEDEX · ReferencePrescription
DEXMEDETOMIDINE HYDROCHLORIDE EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) · INJECTABLE · INJECTION
PRECEDEX · ReferencePrescription
DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) · INJECTABLE · INJECTION
PRECEDEX · ReferencePrescription
DEXMEDETOMIDINE HYDROCHLORIDE EQ 1MG BASE/250ML (EQ 4MCG BASE/ML) · INJECTABLE · INJECTION
PRECEDEX · ReferencePrescription
DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) · INJECTABLE · INJECTION
PRECEDEX · ReferencePrescription
DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) · INJECTABLE · INJECTION

Approval history

2026-05-01Labeling · Supplement 61 · standard — Letter ↗AP
2024-10-11UNKNOWN · Supplement 55 · unknown — Label ↗AP
2022-12-16Efficacy · Supplement 28 · standard — Label ↗AP
2022-08-12Labeling · Supplement 33 · standard — Letter ↗AP
2022-08-12Labeling · Supplement 31 · standard — Letter ↗AP
2020-01-31Manufacturing (CMC) · Supplement 35 — Letter ↗AP
2016-04-11Labeling · Supplement 27 · standard — Letter ↗AP
2014-11-14Labeling · Supplement 26 · standard — Label ↗AP
2014-11-14Manufacturing (CMC) · Supplement 24 · standard — Label ↗AP
2014-11-14Labeling · Supplement 19 · standard — Letter ↗AP
2014-04-18Manufacturing (CMC) · Supplement 16 · standardAP
2014-01-16Manufacturing (CMC) · Supplement 25 · standardAP
2013-09-28Manufacturing (CMC) · Supplement 23 · standardAP
2013-06-17Efficacy · Supplement 21 · priority — Letter ↗AP
2013-06-17Efficacy · Supplement 22 · priority — Pediatric Written Request ↗AP
2013-03-13Manufacturing (CMC) · Supplement 20 · standard — Review ↗AP
2010-10-13Labeling · Supplement 17 · unknown — Letter ↗AP
2008-10-17Efficacy · Supplement 10 · unknown — Letter ↗AP
2001-05-08Manufacturing (CMC) · Supplement 2 · standardAP
2001-01-16Labeling · Supplement 1 · standardAP
1999-12-17Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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