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Serving leading biopharmaceutical companies globally:

Cipla
Merck
Teva
QuintilesIMS
Moodys
Novartis
Accenture
Colorcon
Fish and Richardson
Baxter

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 086724

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NDA 086724 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 086724
Tradename:LIDOCAINE
Applicant:Taro
Ingredient:lidocaine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 086724
Ingredient-typeAmides
Physiological EffectLocal Anesthesia
Medical Subject Heading (MeSH) Categories for 086724
Suppliers and Packaging for NDA: 086724
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIDOCAINE lidocaine OINTMENT;TOPICAL 086724 ANDA Pharmaceutica North America, Inc 45861-061 45861-061-30 1 TUBE in 1 CARTON (45861-061-30) > 30 g in 1 TUBE
LIDOCAINE lidocaine OINTMENT;TOPICAL 086724 ANDA Pharmaceutica North America, Inc. 45861-065 45861-065-60 2 TUBE in 1 CARTON (45861-065-60) > 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength5%
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:No

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Serving leading biopharmaceutical companies globally:

Queensland Health
Accenture
Mallinckrodt
Boehringer Ingelheim
US Department of Justice
Teva
Cantor Fitzgerald
Johnson and Johnson
McKesson

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