APPLICATION
ANDA076092
TYPE
ANDA
ORIGINAL APPROVAL
2001-12-28
LATEST ACTION
2023-06-23
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
KETAMINE HYDROCHLORIDEPrescription
KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML · INJECTABLE · INJECTION
Approval history
2023-06-23Labeling · Supplement 29 · standardAP
2018-12-31Labeling · Supplement 23 · standardAP
2012-10-05Labeling · Supplement 18 · standardAP
2008-09-30Labeling · Supplement 9AP
2002-10-25Manufacturing (CMC) · Supplement 1AP
2002-10-25Labeling · Supplement 2AP
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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