Orange Book product · Brand (NDA)
KETALAR
KETAMINE HYDROCHLORIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
KETAMINE HYDROCHLORIDE
Strength
EQ 50MG BASE/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 016812
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2025KETAMINE HYDROCHLORIDEGeneric (ANDA)
ANDA 219684 · BAXTER HLTHCARE CORP
- 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.
