← FDA DRUG APPROVALS

FDA NDA · NDA020478

ULTANE

sevoflurane

Sponsor: ABBVIE

APPLICATION
NDA020478
TYPE
NDA
ORIGINAL APPROVAL
1995-06-07
LATEST ACTION
2025-02-03
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
LIQUID
MARKETING STATUS
Prescription

Products

ULTANE · ReferencePrescription
SEVOFLURANE 100% · LIQUID · INHALATION

Approval history

2025-02-03Labeling · Supplement 35 · standard — Label ↗AP
2022-11-01Labeling · Supplement 34 · standard — Letter ↗AP
2022-05-19Labeling · Supplement 32 · standard — Label ↗AP
2022-03-01Labeling · Supplement 27 · standard — Letter ↗AP
2022-03-01Labeling · Supplement 23 · standard — Letter ↗AP
2022-03-01Labeling · Supplement 28 · standard — Letter ↗AP
2022-03-01Labeling · Supplement 24 · standard — Letter ↗AP
2017-04-27Labeling · Supplement 30 · standard — Label ↗AP
2015-10-26Manufacturing (CMC) · Supplement 29 · standard — Label ↗AP
2014-03-11Labeling · Supplement 25 · standard — Label ↗AP
2014-03-11Labeling · Supplement 26 · standard — Letter ↗AP
2012-08-16Labeling · Supplement 19 · standard — Label ↗AP
2012-08-16Labeling · Supplement 20 · standard — Label ↗AP
2010-01-21Labeling · Supplement 18 · standard — Letter ↗AP
2006-06-27Labeling · Supplement 16 · standard — Letter ↗AP
2005-06-21Labeling · Supplement 13 · standard — Letter ↗AP
2003-06-27Labeling · Supplement 12 · standard — Letter ↗AP
2002-12-11Labeling · Supplement 7 · standard — Review ↗AP
2002-05-24Manufacturing (CMC) · Supplement 11 · standard — Review ↗AP
2001-09-28Manufacturing (CMC) · Supplement 9 · standardAP
2001-08-09Labeling · Supplement 10 · standardAP
2001-03-30Efficacy · Supplement 6 · standard — Label ↗AP
2001-03-14Manufacturing (CMC) · Supplement 8 · standardAP
2000-06-16Manufacturing (CMC) · Supplement 4 · standardAP
1998-08-06Labeling · Supplement 3 · standardAP
1997-12-23Labeling · Supplement 2 · standardAP
1997-07-02Manufacturing (CMC) · Supplement 1 · standardAP
1995-06-07Type 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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