Viewing data from:

LIDOCAINE

ANDA

LIDOCAINE | A205318 | ENCUBE ETHICALS PRIVATE LTD

1 strength0 unique patents0 unique exclusivities

API Supply Chain14 active DMFs8 inactive

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

SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRLLIDOCAINE BASE CRYSTALLIZED & LIDOCAINE HcL

DMF 41391981

W R GRACE AND CO -CONNLIDOCAINE HCL, USP, BP & PH EUR

DMF 43231981

DELTA SYNTHETIC CO LTDLIDOCAINE

DMF 113391995

W R GRACE AND CO -CONNLIDOCAINE USP

DMF 115641995

MOEHS IBERICA SLLIDOCAINE

DMF 132351998

SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRLLIDOCAINE BASE

DMF 183182005

CAMBREX KARLSKOGA ABLIDOCAINE

DMF 195322006

MAHENDRA CHEMICALSLIDOCAINE USP

DMF 240502010

SWATI SPENTOSE PRIVATE LTDLIDOCAINE USP

DMF 258302012

HARMAN FINOCHEM LTDLIDOCAINE USP

DMF 271802013

HARMAN FINOCHEM LTDLIDOCAINE HCL USP

DMF 287842014

APEX HEALTHCARE LTDLIDOCAINE USP

DMF 341092019

SHIJIAZHUANG CANSAV PHARMACEUTICAL TECHNOLOGY CO LTDLIDOCAINE

DMF 408002024

THE MOLECULEZLIDOCAINE IP/BP/EP/USP

DMF 433162025

SANOFI PHARMACEUTICALS INCInactiveLIDOCAINE HCL

DMF 28011976

WARD BLENKINSOP AND CO LTDInactiveLIDOCAINE (LIGNOCAINE)

DMF 31371978

PROFARMACO SRLInactiveLIDOCAINE HCL & BASE---2-(diethylamino)-2-6 acetoxylidide hcl

DMF 41401981

NAPP CHEMICALS INCInactiveLIDOCAINE HCL

DMF 41821981

ORGAMOL SAInactiveLIDOCAINE BASE / LIDOCAINE HCL

DMF 43301981

MEDICHEM SAInactiveLIDOCAINE BASE & LIDOCAINE HYDROCHLORIDE

DMF 56641985

SYN-TECH CHEM AND PHARM CO LTDInactiveLIDOCAINE USP

DMF 180052005

GUFIC BIOSCIENCES LTDInactiveLIDOCAINE USP

DMF 207892007

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 3, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5%

0 patents0 exclusivities▴

OINTMENT;TOPICAL | Approved: Feb 1, 2016

No patent or exclusivity listings for this strength.