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LIDOCAINE HYDROCHLORIDE

ANDA

LIDOCAINE HYDROCHLORIDE | A080407 | WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: XYLOCAINE(TE code: AP)

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Foley & Lardner, LLP FDA-2020-P-1252 Foley & Lardner LLP filed an ANDA Suitability Petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that FDA determine a 2 mL fill vial formulation of Lidocaine Hydrochloride Injection USP 10 mg/mL is suitable for ANDA submission, with the formulation being quant	Suitability	2020-04-07	Open	Foley & Lardner

Source: Regulations.gov. FDA citizen petitions matched by application number.

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 (2)

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#001 — 1%

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 2%

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982