APPLICATION
ANDA074524
TYPE
ANDA
ORIGINAL APPROVAL
1996-03-22
LATEST ACTION
2023-04-12
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
KETAMINE HYDROCHLORIDEPrescription
KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML · INJECTABLE · INJECTION
KETAMINE HYDROCHLORIDEPrescription
KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML · INJECTABLE · INJECTION
Approval history
2023-04-12Labeling · Supplement 19 · standardAP
2021-04-07Labeling · Supplement 18 · standardAP
2020-06-03Labeling · Supplement 14 · standardAP
2020-06-03Labeling · Supplement 15 · standardAP
2012-10-11Labeling · Supplement 10 · standardAP
2001-04-03Manufacturing (CMC) · Supplement 3AP
1999-09-24Labeling · Supplement 1AP
1996-03-22OriginalAP
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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