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Generated: June 29, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040911

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NDA 040911 describes LIDOCAINE, which is a drug marketed by Alkem Labs Ltd, Belmora Llc, Septodont Inc, Teligent Pharma Inc, Taro, Mylan Technologies, Actavis Labs Ut Inc, Amneal Pharms, Fougera Pharms Inc, Glenmark Pharms Ltd, Tolmar, Fougera Pharms, Hi Tech Pharma, Intl Medication, West-ward Pharms Int, Abraxis Pharm, Bel Mar, Vintage, Hospira, Miles, G And W Labs Inc, Elkins Sinn, Watson Labs, Akorn, Gd Searle Llc, Watson Labs Inc, Mylan Labs Ltd, Luitpold, Abbott, Luitpold Pharms Inc, Wockhardt, Wyeth Ayerst, Dell Labs, Paco, Lyphomed, Baxter Hlthcare, B Braun, Eastman Kodak, Empi, Fresenius Kabi Usa, Aurobindo Pharma Ltd, and Actavis Mid Atlantic, and is included in one hundred and seven NDAs. It is available from thirty suppliers. Additional details are available on the LIDOCAINE profile page.

The generic ingredient in LIDOCAINE is epinephrine; lidocaine hydrochloride. There are nineteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.

Summary for NDA: 040911

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

Pharmacology for NDA: 040911

Ingredient-typeAmides
Physiological EffectLocal Anesthesia

Suppliers and Packaging for NDA: 040911

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIDOCAINE
lidocaine
OINTMENT;TOPICAL 040911 ANDA Septodont, Inc. 0362-0221 0362-0221-10 50 g in 1 JAR (0362-0221-10)
LIDOCAINE
lidocaine
OINTMENT;TOPICAL 040911 ANDA Hi-Tech Pharmacal Co., Inc. 50383-933 50383-933-35 1 TUBE in 1 CARTON (50383-933-35) > 35.44 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength5%
Approval Date:May 23, 2011TE:ATRLD:No


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Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Johnson and Johnson
Cantor Fitzgerald
Healthtrust
UBS
Colorcon
Deloitte
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Accenture

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