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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 nine 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

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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 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 PRESERVATIVE FREE
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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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