APPLICATION
NDA016812
TYPE
NDA
ORIGINAL APPROVAL
1970-02-19
LATEST ACTION
2026-03-23
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
KETALAR · ReferencePrescription
KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML · INJECTABLE · INJECTION
KETALAR · ReferencePrescription
KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML · INJECTABLE · INJECTION
KETALAR · ReferencePrescription
KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML · INJECTABLE · INJECTION
Approval history
2026-03-20Labeling · Supplement 59 · standardAP
2001-02-14Labeling · Supplement 26 · standardAP
2000-03-29Manufacturing (CMC) · Supplement 30 · priorityAP
2000-03-14Labeling · Supplement 29 · standardAP
1998-11-17Manufacturing (CMC) · Supplement 28 · priorityAP
1997-09-05Manufacturing (CMC) · Supplement 27 · priorityAP
1994-11-29Manufacturing (CMC) · Supplement 25 · priorityAP
1989-02-07Manufacturing (CMC) · Supplement 24 · priorityAP
1982-06-11Efficacy · Supplement 23AP
1980-08-18Labeling · Supplement 22AP
1980-04-04Manufacturing (CMC) · Supplement 21 · priorityAP
1980-04-04Labeling · Supplement 20AP
1977-07-05Labeling · Supplement 19AP
1977-05-16Labeling · Supplement 18AP
1977-05-16Manufacturing (CMC) · Supplement 17 · priorityAP
1977-01-28Labeling · Supplement 15AP
1976-05-14Labeling · Supplement 14AP
1970-02-19Type 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.
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