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Last Updated: July 10, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 080408


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NDA 080408 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 nine NDAs. It is available from ten 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. Thirty-seven suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
Summary for 080408
Tradename:LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
Applicant:Hospira
Ingredient:lidocaine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 080408
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 080408
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE lidocaine hydrochloride INJECTABLE;INJECTION 080408 ANDA Hospira, Inc. 0409-4713 0409-4713-02 5 CELLO PACK in 1 PACKAGE (0409-4713-02) > 5 AMPULE in 1 CELLO PACK (0409-4713-26) > 5 mL in 1 AMPULE (0409-4713-12)
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE lidocaine hydrochloride INJECTABLE;INJECTION 080408 ANDA Hospira, Inc. 0409-4713 0409-4713-32 5 CARTON in 1 PACKAGE (0409-4713-32) > 10 AMPULE in 1 CARTON (0409-4713-25) > 2 mL in 1 AMPULE (0409-4713-42)

Profile for product number 001

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

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1.5%
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

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