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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Federal Trade Commission
Daiichi Sankyo
Deloitte
Chubb
Fuji
Johnson and Johnson
Merck
Teva

Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 080404

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NDA 080404 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 seven 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-three suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
Summary for 080404
Tradename:LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
Applicant:Fresenius Kabi Usa
Ingredient:lidocaine hydrochloride
Patents:0
Therapeutic Class:Anesthetics
Formulation / Manufacturing:see details
Pharmacology for NDA: 080404
Ingredient-typeAmides
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 080404
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE lidocaine hydrochloride INJECTABLE;INJECTION 080404 ANDA Cardinal Health 55154-9378 E 55154-9378-5
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE lidocaine hydrochloride INJECTABLE;INJECTION 080404 ANDA US MedSource, LLC 61699-0201 E 61699-0201-1

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1%
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2%
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Fish and Richardson
Cantor Fitzgerald
Medtronic
Moodys
Chubb
US Army
Merck
Harvard Business School

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