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Last Updated: January 22, 2020

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Details for New Drug Application (NDA): 020612

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NDA 020612 describes LIDODERM, which is a drug marketed by Teikoku Pharma Usa and is included in one NDA. It is available from four suppliers. Additional details are available on the LIDODERM profile page.

The generic ingredient in LIDODERM is lidocaine. There are twenty-nine drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the lidocaine profile page.
Summary for 020612
Tradename:LIDODERM
Applicant:Teikoku Pharma Usa
Ingredient:lidocaine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020612
Physiological EffectLocal Anesthesia
Medical Subject Heading (MeSH) Categories for 020612
Suppliers and Packaging for NDA: 020612
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIDODERM lidocaine PATCH;TOPICAL 020612 NDA AUTHORIZED GENERIC Par Pharmaceutical 0603-1880 0603-1880-16 30 POUCH in 1 CARTON (0603-1880-16) > 1 g in 1 POUCH (0603-1880-10)
LIDODERM lidocaine PATCH;TOPICAL 020612 NDA Lake Erie Medical DBA Quality Care Products LLC 49999-419 49999-419-30 30 POUCH in 1 CARTON (49999-419-30) > 1 g in 1 POUCH
Paragraph IV (Patent) Challenges for 020612
Tradename Dosage Ingredient NDA Submissiondate
LIDODERM PATCH;TOPICAL lidocaine 020612 2009-11-13

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:PATCH;TOPICALStrength5%
Approval Date:Mar 19, 1999TE:ABRLD:Yes

Expired US Patents for NDA 020612

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teikoku Pharma Usa LIDODERM lidocaine PATCH;TOPICAL 020612-001 Mar 19, 1999   Start Trial   Start Trial
Teikoku Pharma Usa LIDODERM lidocaine PATCH;TOPICAL 020612-001 Mar 19, 1999   Start Trial   Start Trial
Teikoku Pharma Usa LIDODERM lidocaine PATCH;TOPICAL 020612-001 Mar 19, 1999   Start Trial   Start Trial
Teikoku Pharma Usa LIDODERM lidocaine PATCH;TOPICAL 020612-001 Mar 19, 1999   Start Trial   Start Trial
Teikoku Pharma Usa LIDODERM lidocaine PATCH;TOPICAL 020612-001 Mar 19, 1999   Start Trial   Start Trial
Teikoku Pharma Usa LIDODERM lidocaine PATCH;TOPICAL 020612-001 Mar 19, 1999   Start Trial   Start Trial
Teikoku Pharma Usa LIDODERM lidocaine PATCH;TOPICAL 020612-001 Mar 19, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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