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Generated: January 19, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040837

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NDA 040837 describes LIDOCAINE HYDROCHLORIDE, which is a drug marketed by Abbott, Abraxis Pharm, Akorn, Aurobindo Pharma Ltd, B Braun Medical Inc, Bel Mar, Belmora Llc, Dell Labs, Elkins Sinn, Gd Searle Llc, Hospira, Intl Medication, Luitpold, Lyphomed, Miles, Mylan Labs Ltd, Spectra Mdcl Devices, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, G And W Labs Inc, Watson Labs Inc, Hi Tech Pharma, Wockhardt Bio Ag, Lannett Co Inc, Paco, Teligent Pharma Inc, Baxter Hlthcare, B Braun, Eastman Kodak, Empi, Fresenius Kabi Usa, and Actavis Mid Atlantic, and is included in ninety-six NDAs. It is available from thirty-two suppliers. Additional details are available on the LIDOCAINE HYDROCHLORIDE profile page.

The generic ingredient in LIDOCAINE HYDROCHLORIDE is epinephrine; lidocaine hydrochloride. There are twenty-one 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 040837
Tradename:LIDOCAINE HYDROCHLORIDE
Applicant:Watson Labs Inc
Ingredient:lidocaine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040837
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 040837
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride JELLY;TOPICAL 040837 ANDA Actavis Pharma, Inc. 0591-3012 0591-3012-26 1 TUBE, WITH APPLICATOR in 1 CARTON (0591-3012-26) > 5 mL in 1 TUBE, WITH APPLICATOR
LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride JELLY;TOPICAL 040837 ANDA Actavis Pharma, Inc. 0591-3012 0591-3012-30 1 TUBE, WITH APPLICATOR in 1 CARTON (0591-3012-30) > 30 mL in 1 TUBE, WITH APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:JELLY;TOPICALStrength2%
Approval Date:Mar 23, 2011TE:RLD:No

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