APPLICATION
NDA011559
TYPE
NDA
ORIGINAL APPROVAL
1960-06-27
LATEST ACTION
2020-11-03
ROUTE
INTRAMUSCULAR, INTRAVENOUS, RECTAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription
Products
BREVITAL SODIUMDiscontinued
METHOHEXITAL SODIUM 5GM/VIAL · INJECTABLE · INJECTION
BREVITAL SODIUM · ReferencePrescription
METHOHEXITAL SODIUM 500MG/VIAL · INJECTABLE · INJECTION
BREVITAL SODIUMDiscontinued
METHOHEXITAL SODIUM 200MG/VIAL · INJECTABLE · INJECTION
BREVITAL SODIUM · ReferenceDiscontinued
METHOHEXITAL SODIUM 2.5GM/VIAL · INJECTABLE · INJECTION
Approval history
2014-12-15Manufacturing (CMC) · Supplement 48 · standardAP
2014-09-22Manufacturing (CMC) · Supplement 47 · standardAP
1998-01-30Efficacy · Supplement 28 · unknownAP
1998-01-30Efficacy · Supplement 29 · unknownAP
1997-12-17Labeling · Supplement 30 · standardAP
1996-07-25Manufacturing (CMC) · Supplement 27 · standardAP
1996-02-29Manufacturing (CMC) · Supplement 26 · standardAP
1995-11-02Manufacturing (CMC) · Supplement 25 · standardAP
1994-06-14Manufacturing (CMC) · Supplement 24 · standardAP
1992-12-18Labeling · Supplement 18AP
1992-12-02Labeling · Supplement 21 · standardAP
1988-07-08Labeling · Supplement 14AP
1981-07-01Manufacturing (CMC) · Supplement 12 · standardAP
1979-10-04Manufacturing (CMC) · Supplement 10 · standardAP
1976-05-14Labeling · Supplement 9AP
1975-06-13Labeling · Supplement 8AP
1969-12-11Labeling · Supplement 4AP
1960-06-27Type 1 - New Molecular Entity · Original · 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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