← FDA DRUG APPROVALS

FDA NDA · NDA020630

ULTIVA

remifentanil hydrochloride

Sponsor: MYLAN INSTITUTIONAL

APPLICATION
NDA020630
TYPE
NDA
ORIGINAL APPROVAL
1996-07-12
LATEST ACTION
2025-12-22
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ULTIVA · ReferencePrescription
REMIFENTANIL HYDROCHLORIDE EQ 5MG BASE/VIAL · INJECTABLE · INJECTION
ULTIVA · ReferencePrescription
REMIFENTANIL HYDROCHLORIDE EQ 1MG BASE/VIAL · INJECTABLE · INJECTION
ULTIVA · ReferencePrescription
REMIFENTANIL HYDROCHLORIDE EQ 2MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

2025-12-22Labeling · Supplement 33 · standard — Letter ↗AP
2025-12-22Labeling · Supplement 31 · standard — Letter ↗AP
2023-12-15Labeling · Supplement 30 · standard — Label ↗AP
2019-10-07Labeling · Supplement 20 · standard — Letter ↗AP
2018-06-21Labeling · Supplement 18 · standard — Label ↗AP
2016-12-16Labeling · Supplement 16 · standard — Letter ↗AP
2016-01-12Manufacturing (CMC) · Supplement 15 · standardAP
2013-06-11Manufacturing (CMC) · Supplement 14 · standardAP
2004-03-08Efficacy · Supplement 5 · standard — Label ↗AP
2002-12-20Manufacturing (CMC) · Supplement 8 · standardAP
2002-10-03Manufacturing (CMC) · Supplement 9 · standardAP
2001-11-19Manufacturing (CMC) · Supplement 7 · standardAP
2000-09-19Manufacturing (CMC) · Supplement 6 · standardAP
1999-11-23Efficacy · Supplement 2 · standardAP
1999-10-15Efficacy · Supplement 1 · standardAP
1999-06-23Labeling · Supplement 3 · standardAP
1996-07-12Type 1 - New Molecular Entity · Original · standard — Review ↗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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