Orange Book product · Generic (ANDA)
KETAMINE HYDROCHLORIDE
KETAMINE HYDROCHLORIDE
At a glance
Aug 07, 2025
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 07, 2025
11 mo ago
Today
Pharmaceutical detail
Active ingredient
KETAMINE HYDROCHLORIDE
Strength
EQ 10MG BASE/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
ANDA 217858
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 219684 · BAXTER HLTHCARE CORP
- 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.
