APPLICATION
ANDA074416
TYPE
ANDA
ORIGINAL APPROVAL
1994-09-30
LATEST ACTION
2024-01-08
ROUTE
RESPIRATORY (INHALATION), INHALATION
DOSAGE FORM
LIQUID
MARKETING STATUS
Prescription
Products
ISOFLURANEPrescription
ISOFLURANE 99.9% · LIQUID · INHALATION
Approval history
2024-01-08Labeling · Supplement 8 · standardAP
2024-01-08Labeling · Supplement 11 · standardAP
2024-01-08Labeling · Supplement 12 · standardAP
2024-01-08Labeling · Supplement 10 · standardAP
2015-02-06Labeling · Supplement 7AP
2000-06-07Manufacturing (CMC) · Supplement 4AP
2000-06-07Labeling · Supplement 3AP
2000-01-03Manufacturing (CMC) · Supplement 5AP
1996-08-15Labeling · Supplement 1AP
1994-09-30OriginalAP
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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