Viewing data from:

KETAMINE HYDROCHLORIDE

ANDA

KETAMINE HYDROCHLORIDE | A219684 | BAXTER HEALTHCARE CORP

1 strength0 unique patents0 unique exclusivities

API Supply Chain6 active DMFs2 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

CU CHEMIE UETIKON GMBHKETAMINE HYDROCHLORIDE

DMF 76861988

FINE ORGANICS LTDKETAMINE HYDROCHLORIDE

DMF 190822005

SUPRIYA LIFESCIENCE LTDKETAMINE HYDROCHLORIDE USP

DMF 279212014

AREVIPHARMA GMBHKETAMINE HYDROCHLORIDE

DMF 290942015

GLAND PHARMA LTDKETAMINE HYDROCHLORIDE

DMF 353852020

MAITHRI DRUGS PRIVATE LTDKETAMINE HYDROCHLORIDE USP

DMF 370142022

DEGUSSA AG WERK RADEBEULInactiveKETAMINE HYDROCHLORIDE

DMF 131411998

KAMUD DRUGS PVT LTDInactiveKETAMINE HYDROCHLORIDE USP

DMF 222562008

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — EQ 100MG BASE/10ML (EQ 10MG BASE/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAMUSCULAR, INTRAVENOUS | Approved: Sep 17, 2025

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDtype7/1/2026

Baxter Healthcare Corp.'s KETAMINE HYDROCHLORIDE (NDA 219684) transitioned from prescription (RX) to discontinued (DISCN) status.

Old: RX

New: DISCN

MODIFIEDrs7/1/2026

Baxter Healthcare's Ketamine Hydrochloride (NDA 219684) was removed from the Rx-to-OTC switch status.

Old: Yes

New: No