Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Generated: August 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207810

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NDA 207810 describes LIDOCAINE, which is a drug marketed by Acp Nimble, Aleor Dermaceuticals, Alkem Labs Ltd, Amneal Pharms, Belmora Llc, Fougera Pharms Inc, Glenmark Pharms Ltd, Riconpharma Llc, Septodont Inc, Strides Pharma, 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, B Braun Medical Inc, Bel Mar, Dell Labs, Elkins Sinn, Fresenius Kabi Usa, Gd Searle Llc, Hospira, Intl Medication, Luitpold, Lyphomed, Miles, Mylan Labs Ltd, Spectra Mdcl Devices, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Watson Labs Inc, Wockhardt Bio Ag, Lannett Co Inc, Paco, Baxter Hlthcare, B Braun, Eastman Kodak, Empi, and Actavis Mid Atlantic, and is included in one hundred and seventeen NDAs. It is available from forty-two suppliers. Additional details are available on the LIDOCAINE profile page.

The generic ingredient in LIDOCAINE is epinephrine; lidocaine hydrochloride. There are twenty-one drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.
Summary for 207810
Tradename:LIDOCAINE
Applicant:Alkem Labs Ltd
Ingredient:lidocaine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207810
Physiological EffectLocal Anesthesia
Medical Subject Heading (MeSH) Categories for 207810
Suppliers and Packaging for NDA: 207810
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIDOCAINE lidocaine OINTMENT;TOPICAL 207810 ANDA Liberty Pharmaceuticals, Inc. 0440-9715 0440-9715-35 35.44 g in 1 TUBE (0440-9715-35)
LIDOCAINE lidocaine OINTMENT;TOPICAL 207810 ANDA H.J. Harkins Company, Inc. 52959-993 52959-993-50 50 g in 1 TUBE (52959-993-50)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength5%
Approval Date:Mar 10, 2017TE:ATRLD:No

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