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Serving leading biopharmaceutical companies globally:

Novartis
Healthtrust
Johnson and Johnson
AstraZeneca
Colorcon
Cantor Fitzgerald
McKesson
Fish and Richardson
Queensland Health
US Army

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205318

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NDA 205318 describes LIDOCAINE, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms, Belmora Llc, Fougera Pharms Inc, Glenmark Pharms Ltd, Riconpharma Llc, Septodont Inc, Taro, Teligent Pharma Inc, Vitruvias Therap, Actavis Labs Ut Inc, Mylan Technologies, Fougera Pharms, Hi Tech Pharma, Tolmar, Abbott, Abraxis Pharm, Akorn, Aurobindo Pharma Ltd, Bel Mar, Dell Labs, Elkins Sinn, Gd Searle Llc, Hospira, Intl Medication, Luitpold, Luitpold Pharms Inc, Lyphomed, Miles, Mylan Labs Ltd, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, G And W Labs Inc, Watson Labs Inc, Wockhardt, Paco, Vintage, Baxter Hlthcare, B Braun, Eastman Kodak, Empi, Fresenius Kabi Usa, and Actavis Mid Atlantic, and is included in one hundred and ten NDAs. It is available from thirty-five suppliers. Additional details are available on the LIDOCAINE profile page.

The generic ingredient in LIDOCAINE is epinephrine; lidocaine hydrochloride. There are nineteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.
Summary for 205318
Tradename:LIDOCAINE
Applicant:Teligent Pharma Inc
Ingredient:lidocaine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205318
Ingredient-typeAmides
Physiological EffectLocal Anesthesia
Medical Subject Heading (MeSH) Categories for 205318
Suppliers and Packaging for NDA: 205318
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIDOCAINE lidocaine OINTMENT;TOPICAL 205318 ANDA Teligent Pharma, Inc. 52565-008 52565-008-14 1 TUBE in 1 CARTON (52565-008-14) > 35.44 g in 1 TUBE
LIDOCAINE lidocaine OINTMENT;TOPICAL 205318 ANDA Teligent Pharma, Inc. 52565-008 52565-008-55 1 JAR in 1 CARTON (52565-008-55) > 50 g in 1 JAR

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength5%
Approval Date:Feb 1, 2016TE:ATRLD:No

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Serving leading biopharmaceutical companies globally:

Fuji
Colorcon
Daiichi Sankyo
Accenture
Cerilliant
Julphar
US Army
Argus Health
QuintilesIMS

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