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LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE

ANDA

LIDOCAINE HYDROCHLORIDE | A090665 | CHARTWELL RX SCIENCES LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain7 active DMFs4 inactive

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

MOEHS IBERICA SLLIDOCAINE HYDROCHLORIDE

DMF 58761985

DELTA SYNTHETIC CO LTDLIDOCAINE HYDROCHLORIDE

DMF 113381995

CAMBREX KARLSKOGA ABLIDOCAINE HYDROCHLORIDE

DMF 195312006

MAHENDRA CHEMICALSLIDOCAINE HYDROCHLORIDE USP

DMF 240512010

SWATI SPENTOSE PRIVATE LTDLIDOCAINE HYDROCHLORIDE USP

DMF 259632012

APEX HEALTHCARE LTDLIDOCAINE HYDROCHLORIDE USP

DMF 391392023

SHIJIAZHUANG CANSAV PHARMACEUTICAL TECHNOLOGY CO LTDLIDOCAINE HYDROCHLORIDE

DMF 408142024

HOECHST AGInactiveLIDOCAINE HYDROCHLORIDE AND BASE(BULK

DMF 59211985

GUFIC BIOSCIENCES LTDInactiveLIDOCAINE HYDROCHLORIDE

DMF 174832004

KONDUSKAR LABORATORIES PVT LTDInactiveLIDOCAINE HYDROCHLORIDE USP

DMF 240562010

APEX HEALTHCARE LTDInactiveLIDOCAINE HYDROCHLORIDE USP

DMF 343072020

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

Products (1)

#001 — 2%

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Sep 27, 2010

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

CHARTWELL RX replaced EXTROVIS as the applicant for lidocaine hydrochloride preservative-free (NDA 090665).

Old: EXTROVIS

New: CHARTWELL RX

MODIFIEDApplicant Full Name7/1/2026

Chartwell RX Sciences LLC replaced Extrovis AG as the listed applicant for lidocaine hydrochloride preservative free (NDA 090665).

Old: EXTROVIS AG

New: CHARTWELL RX SCIENCES LLC