Orange Book product · Generic (ANDA)
KETAMINE HYDROCHLORIDE
KETAMINE HYDROCHLORIDE
At a glance
Sep 17, 2025
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 17, 2025
9 mo ago
Today
Pharmaceutical detail
Active ingredient
KETAMINE HYDROCHLORIDE
Strength
EQ 100MG BASE/10ML (EQ 10MG BASE/ML)
Dosage form
SOLUTION
Route
INTRAMUSCULAR, INTRAVENOUS
TE code
Not listed
Application
ANDA 219684
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of KETAMINE HYDROCHLORIDE
- —KETALARBrand (NDA)
NDA 016812 · PH HEALTH
- 2025KETAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217858 · CAPLIN
- 2023KETAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 216809 · GLAND
- 2023KETAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 215808 · FRESENIUS KABI USA
- 2008KETAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 076092 · EUGIA PHARMA
- 1996KETAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074549 · HOSPIRA
- 1996KETAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 074524 · HIKMA
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
