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KETAMINE HYDROCHLORIDE

ANDA

KETAMINE HYDROCHLORIDE | A076092 | EUGIA PHARMA SPECIALITIES LTD

3 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: KETALAR(TE code: AP)

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.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 16, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

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#001 — EQ 10MG BASE/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Sep 30, 2008

No patent or exclusivity listings for this strength.

#002 — EQ 50MG BASE/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 28, 2001

#003 — EQ 100MG BASE/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 25, 2002