← FDA DRUG APPROVALS

FDA NDA · NDA017624

FORANE

isoflurane

Sponsor: BAXTER HLTHCARE

APPLICATION
NDA017624
TYPE
NDA
ORIGINAL APPROVAL
1979-12-18
LATEST ACTION
2024-12-09
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
LIQUID
MARKETING STATUS
Prescription

Products

FORANE · ReferencePrescription
ISOFLURANE 99.9% · LIQUID · INHALATION

Approval history

2024-12-09Labeling · Supplement 43 · standard — Label ↗AP
2022-11-01Labeling · Supplement 42 · standard — Letter ↗AP
2021-10-25Labeling · Supplement 40 · standard — Letter ↗AP
2017-04-27Labeling · Supplement 41 · standard — Letter ↗AP
2013-02-21Manufacturing (CMC) · Supplement 39 · priorityAP
2010-02-22Labeling · Supplement 36 · unknown — Letter ↗AP
2006-08-31Labeling · Supplement 34 · standard — Letter ↗AP
2002-09-27Manufacturing (CMC) · Supplement 32 · priorityAP
2000-12-01Manufacturing (CMC) · Supplement 31 · priorityAP
1999-07-23Manufacturing (CMC) · Supplement 30 · priorityAP
1999-05-14Labeling · Supplement 29 · standardAP
1998-12-09Manufacturing (CMC) · Supplement 28 · priorityAP
1997-02-26Manufacturing (CMC) · Supplement 27 · priorityAP
1996-07-01Manufacturing (CMC) · Supplement 25 · priorityAP
1996-02-09Manufacturing (CMC) · Supplement 24 · priorityAP
1995-07-05Labeling · Supplement 23 · standardAP
1990-01-16Labeling · Supplement 19AP
1987-02-25Manufacturing (CMC) · Supplement 18 · priorityAP
1986-04-16Labeling · Supplement 16AP
1986-04-16Manufacturing (CMC) · Supplement 17 · priorityAP
1986-04-16Labeling · Supplement 15AP
1985-10-17Labeling · Supplement 14AP
1985-08-02Manufacturing (CMC) · Supplement 12 · priorityAP
1985-03-15Labeling · Supplement 13AP
1984-11-20Manufacturing (CMC) · Supplement 11 · priorityAP
1984-06-12Labeling · Supplement 8AP
1983-04-01Labeling · Supplement 10AP
1983-02-09Manufacturing (CMC) · Supplement 9 · priorityAP
1982-07-01Labeling · Supplement 2AP
1982-02-22Efficacy · Supplement 7AP
1981-09-29Manufacturing (CMC) · Supplement 6 · priorityAP
1981-06-05Manufacturing (CMC) · Supplement 5 · priorityAP
1981-05-26Manufacturing (CMC) · Supplement 3 · priorityAP
1981-05-26Manufacturing (CMC) · Supplement 1 · priorityAP
1981-05-26Labeling · Supplement 4AP
1979-12-18Type 1 - New Molecular Entity · Original · priorityAP
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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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