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Serving leading biopharmaceutical companies globally:

McKesson
QuintilesIMS
Colorcon
Cantor Fitzgerald
Merck
Citi
Cipla
Dow
Fish and Richardson
Medtronic

Generated: December 11, 2017

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 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 080404

Tradename:1
Applicant:1
Ingredient:1
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 55154-9378-5 25 VIAL in 1 TRAY (55154-9378-5) > 10 mL in 1 VIAL
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE lidocaine hydrochloride INJECTABLE;INJECTION 080404 ANDA US MedSource, LLC 61699-0201 61699-0201-1 1 VIAL in 1 BAG (61699-0201-1) > 10 mL in 1 VIAL

Summary for product number 002

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

Summary 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 leading biopharmaceutical companies globally:

McKinsey
Moodys
Fuji
UBS
Medtronic
Johnson and Johnson
Fish and Richardson
Citi
US Department of Justice
Express Scripts

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