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Generated: May 25, 2017

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Details for New Drug Application (NDA): 203082

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NDA 203082 describes LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, which is a drug marketed by Intl Medication, Fresenius Kabi Usa, Hospira, West-ward Pharms Int, Aurobindo Pharma Ltd, and Mylan Labs Ltd, and is included in ten 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. Fifty-one suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.

Summary for NDA: 203082

Therapeutic Class:Anesthetics
Formulation / Manufacturing:see details

Pharmacology for NDA: 203082

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
INJECTABLE;INJECTION 203082 ANDA A-S Medication Solutions 50090-2496 50090-2496-1 10 VIAL, SINGLE-DOSE in 1 CARTON (50090-2496-1) > 5 mL in 1 VIAL, SINGLE-DOSE
lidocaine hydrochloride
INJECTABLE;INJECTION 203082 ANDA AuroMedics Pharma LLC 55150-161 55150-161-02 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-161-02) > 2 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

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

Summary for product number 002

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

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