FDA Orange Book · active-ingredient family
Ketamine hydrochloride
Ketamine hydrochloride is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:KETALAR · NDA 016812
1
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| KETALARRLD×3 | PH HEALTH | NDA 016812 | AP | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| KETAMINE HYDROCHLORIDE | BAXTER HLTHCARE CORP | ANDA 219684 | — | Sep 17, 2025 | |
| KETAMINE HYDROCHLORIDE | CAPLIN | ANDA 217858 | — | Aug 07, 2025 | |
| KETAMINE HYDROCHLORIDE×3 | GLAND | ANDA 216809 | AP | Jan 24, 2023 | |
| KETAMINE HYDROCHLORIDE×3 | FRESENIUS KABI USA | ANDA 215808 | AP | Jan 13, 2023 | |
| KETAMINE HYDROCHLORIDE×3 | EUGIA PHARMA | ANDA 076092 | AP | Sep 30, 2008 | |
| KETAMINE HYDROCHLORIDE×2 | HOSPIRA | ANDA 074549 | AP | Jun 27, 1996 | |
| KETAMINE HYDROCHLORIDE×2 | HIKMA | ANDA 074524 | AP | Mar 22, 1996 |
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.
Ketamine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
