APPLICATION
ANDA074549
TYPE
ANDA
ORIGINAL APPROVAL
1996-06-27
LATEST ACTION
2023-04-12
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
KETAMINE HYDROCHLORIDEPrescription
KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML · INJECTABLE · INJECTION
KETAMINE HYDROCHLORIDEPrescription
KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML · INJECTABLE · INJECTION
Approval history
2023-04-12Labeling · Supplement 31 · standardAP
2021-07-19Labeling · Supplement 28 · standardAP
2020-04-28Labeling · Supplement 19 · standardAP
2017-11-07Labeling · Supplement 18 · standardAP
2013-06-13Labeling · Supplement 15 · standardAP
2004-08-10Labeling · Supplement 7AP
2003-11-24Labeling · Supplement 4AP
2001-02-14Manufacturing (CMC) · Supplement 3AP
1999-12-13Labeling · Supplement 2AP
1999-08-24Labeling · Supplement 1AP
1996-06-27OriginalAP
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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