← FDA DRUG APPROVALS

FDA NDA · NDA020118

SUPRANE

desflurane

Sponsor: BAXTER HLTHCARE

APPLICATION
NDA020118
TYPE
NDA
ORIGINAL APPROVAL
1992-09-18
LATEST ACTION
2022-11-01
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
LIQUID
MARKETING STATUS
Prescription

Products

SUPRANE · ReferencePrescription
DESFLURANE 100% · LIQUID · INHALATION

Approval history

2022-11-01Labeling · Supplement 26 · standard — Letter ↗AP
2019-03-01Manufacturing (CMC) · Supplement 22 · standard — Label ↗AP
2019-03-01Labeling · Supplement 23 · standard — Label ↗AP
2017-04-27Labeling · Supplement 24 · standard — Letter ↗AP
2016-11-04Labeling · Supplement 21 · standard — Letter ↗AP
2015-02-26Labeling · Supplement 20 · standard — Letter ↗AP
2013-09-27Manufacturing (CMC) · Supplement 19 · standardAP
2013-09-23Labeling · Supplement 18 · standard — Letter ↗AP
2010-04-05Labeling · Supplement 17 · standard — Label ↗AP
2009-04-14Labeling · Supplement 16 · standard — Label ↗AP
2006-12-15Efficacy · Supplement 12 · priority — Pediatric Medical Review ↗AP
2006-08-14Labeling · Supplement 11 · standard — Letter ↗AP
2006-05-08Labeling · Supplement 10 · standard — Label ↗AP
2002-08-08Manufacturing (CMC) · Supplement 8 · standard — Review ↗AP
1999-12-02Manufacturing (CMC) · Supplement 7 · standard — Review ↗AP
1998-12-09Manufacturing (CMC) · Supplement 5 · standardAP
1997-12-16Manufacturing (CMC) · Supplement 4 · standardAP
1995-07-05Labeling · Supplement 2 · standardAP
1993-03-26Manufacturing (CMC) · Supplement 1 · standardAP
1992-09-18Type 1 - New Molecular Entity · Original · standardAP
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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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