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Harvard Business School
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Deloitte
Queensland Health
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Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203082

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NDA 203082 describes LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Aurobindo Pharma Ltd, Fresenius Kabi Usa, Hospira, Intl Medication, Mylan Labs Ltd, and West-ward Pharms Int, and is included in ten NDAs. It is available from eight suppliers. Additional details are available on the LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE profile page.

The generic ingredient in LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
Summary for 203082
Tradename:LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
Applicant:Aurobindo Pharma Ltd
Ingredient:lidocaine hydrochloride
Patents:0
Therapeutic Class:Anesthetics
Formulation / Manufacturing:see details
Pharmacology for NDA: 203082
Ingredient-typeAmides
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 203082
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE lidocaine hydrochloride INJECTABLE;INJECTION 203082 ANDA Terrain Pharmaceuticals 53225-3600 N 53225-3600-1
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE lidocaine hydrochloride INJECTABLE;INJECTION 203082 ANDA AuroMedics Pharma LLC 55150-161 N 55150-161-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1%
Approval Date:Mar 14, 2013TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2%
Approval Date:Mar 14, 2013TE:APRLD:No

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