APPLICATION
NDA017087
TYPE
NDA
ORIGINAL APPROVAL
1972-08-28
LATEST ACTION
2010-01-21
ROUTE
INHALATION
DOSAGE FORM
LIQUID
MARKETING STATUS
Discontinued
Products
ETHRANEDiscontinued
ENFLURANE 99.9% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · LIQUID · INHALATION
Approval history
2000-09-22Manufacturing (CMC) · Supplement 44 · standardAP
1998-12-09Manufacturing (CMC) · Supplement 43 · standardAP
1996-07-01Manufacturing (CMC) · Supplement 42 · standardAP
1995-07-05Labeling · Supplement 41 · standardAP
1990-03-21Manufacturing (CMC) · Supplement 40 · standardAP
1987-02-25Manufacturing (CMC) · Supplement 39 · standardAP
1986-04-16Labeling · Supplement 37AP
1986-04-16Manufacturing (CMC) · Supplement 38 · standardAP
1986-04-16Labeling · Supplement 36AP
1985-04-17Labeling · Supplement 33AP
1985-04-17Labeling · Supplement 31AP
1985-03-24Labeling · Supplement 35AP
1984-06-06Labeling · Supplement 32AP
1984-05-16Manufacturing (CMC) · Supplement 34 · standardAP
1982-02-22Labeling · Supplement 28AP
1981-10-28Manufacturing (CMC) · Supplement 29 · standardAP
1981-09-24Manufacturing (CMC) · Supplement 30 · standardAP
1980-07-24Manufacturing (CMC) · Supplement 27 · standardAP
1980-07-10Labeling · Supplement 25AP
1979-12-04Manufacturing (CMC) · Supplement 26 · standardAP
1979-12-04Manufacturing (CMC) · Supplement 24 · standardAP
1979-09-06Manufacturing (CMC) · Supplement 23 · standardAP
1979-04-16Manufacturing (CMC) · Supplement 22 · standardAP
1978-05-30Manufacturing (CMC) · Supplement 18 · standardAP
1977-10-06Labeling · Supplement 19AP
1977-09-10Manufacturing (CMC) · Supplement 20 · standardAP
1977-05-03Labeling · Supplement 17AP
1976-11-04Manufacturing (CMC) · Supplement 16 · standardAP
1976-11-04Manufacturing (CMC) · Supplement 15 · standardAP
1976-09-03Manufacturing (CMC) · Supplement 14 · standardAP
1976-03-26Labeling · Supplement 11AP
1975-10-07Manufacturing (CMC) · Supplement 13 · standardAP
1975-08-04Manufacturing (CMC) · Supplement 12 · standardAP
1975-07-16Manufacturing (CMC) · Supplement 9 · standardAP
1975-06-18Manufacturing (CMC) · Supplement 10 · standardAP
1974-11-11Manufacturing (CMC) · Supplement 8 · standardAP
1974-07-17Supplement · Supplement 4 · standardAP
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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