APPLICATION
NDA011338
TYPE
NDA
ORIGINAL APPROVAL
1958-03-12
LATEST ACTION
1996-04-29
ROUTE
INHALATION
DOSAGE FORM
LIQUID
MARKETING STATUS
Discontinued
Products
FLUOTHANEDiscontinued
HALOTHANE 99.99% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · LIQUID · INHALATION
Approval history
1996-04-29Manufacturing (CMC) · Supplement 18 · priorityAP
1996-04-29Manufacturing (CMC) · Supplement 17 · priorityAP
1994-02-28Manufacturing (CMC) · Supplement 16 · priorityAP
1987-07-30Manufacturing (CMC) · Supplement 14 · priorityAP
1987-07-30Labeling · Supplement 15 · priorityAP
1982-10-01Manufacturing (CMC) · Supplement 13 · priorityAP
1981-12-03Manufacturing (CMC) · Supplement 11 · priorityAP
1981-12-01Manufacturing (CMC) · Supplement 8 · priorityAP
1981-12-01Labeling · Supplement 9 · priorityAP
1979-12-04Labeling · Supplement 7 · priorityAP
1978-10-23Labeling · Supplement 6 · priorityAP
1975-10-28Manufacturing (CMC) · Supplement 4 · priorityAP
1975-10-28Labeling · Supplement 5 · priorityAP
1958-03-12Type 1 - New Molecular Entity · Original · priorityAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.