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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 seventeen 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. Thirty-eight suppliers are listed for this compound. Additional details are available on the lidocaine profile page.

Summary for NDA: 020612

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 020612

Ingredient-typeAmides
Physiological EffectLocal Anesthesia

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 Qualitest Pharmaceuticals 0603-1880 0603-1880-16 30 POUCH in 1 CARTON (0603-1880-16) > 1 PATCH in 1 POUCH (0603-1880-10)
LIDODERM
lidocaine
PATCH;TOPICAL 020612 NDA STAT RX USA LLC 16590-141 16590-141-30 30 PATCH in 1 CARTON (16590-141-30)

Summary for product number 001

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

Expired Orange Book Patents for NDA: 020612

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teikoku Pharma Usa
LIDODERM
lidocaine
PATCH;TOPICAL020612-001Mar 19, 19995,411,738► Subscribe
Teikoku Pharma Usa
LIDODERM
lidocaine
PATCH;TOPICAL020612-001Mar 19, 19995,709,869► Subscribe
Teikoku Pharma Usa
LIDODERM
lidocaine
PATCH;TOPICAL020612-001Mar 19, 19995,741,510► Subscribe
Teikoku Pharma Usa
LIDODERM
lidocaine
PATCH;TOPICAL020612-001Mar 19, 19995,827,529► Subscribe
Teikoku Pharma Usa
LIDODERM
lidocaine
PATCH;TOPICAL020612-001Mar 19, 19995,601,838► Subscribe
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