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Generated: April 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, Teva Pharms Usa, 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 Bio Ag, Paco, Vintage, Baxter Hlthcare, B Braun, Eastman Kodak, Empi, Fresenius Kabi Usa, and Actavis Mid Atlantic, and is included in one hundred and eleven NDAs. It is available from thirty-two 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. Ten 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 N 52565-008-55
LIDOCAINE lidocaine OINTMENT;TOPICAL 205318 ANDA Teligent Pharma, Inc. 52565-008 N 52565-008-14

Profile for product number 001

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

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