APPLICATION
ANDA074502
TYPE
ANDA
ORIGINAL APPROVAL
1995-06-27
LATEST ACTION
2024-07-08
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
LIQUID
MARKETING STATUS
Prescription
Products
ISOFLURANEPrescription
ISOFLURANE 99.9% · LIQUID · INHALATION
Approval history
2024-07-08Labeling · Supplement 28 · standardAP
2024-07-08Labeling · Supplement 26 · standardAP
2024-07-08Labeling · Supplement 27 · standardAP
2009-08-10Labeling · Supplement 19AP
2002-03-14Manufacturing (CMC) · Supplement 13AP
2001-10-12Labeling · Supplement 11AP
2001-09-07Manufacturing (CMC) · Supplement 12AP
2001-01-31Manufacturing (CMC) · Supplement 4AP
2000-09-18Manufacturing (CMC) · Supplement 10AP
1997-02-28Manufacturing (CMC) · Supplement 2AP
1996-10-18Labeling · Supplement 3AP
1996-05-24Manufacturing (CMC) · Supplement 1AP
1995-06-27OriginalAP
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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