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Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202346

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NDA 202346 describes LIDOCAINE, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms, Belmora Llc, Fougera Pharms Inc, Glenmark Pharms Ltd, Riconpharma Llc, Septodont Inc, Taro, Teligent Pharma Inc, Vitruvias Therap, Actavis Labs Ut Inc, Mylan Technologies, Fougera Pharms, Hi Tech Pharma, Tolmar, Abbott, Abraxis Pharm, Akorn, Aurobindo Pharma Ltd, Bel Mar, Dell Labs, Elkins Sinn, Gd Searle Llc, Hospira, Intl Medication, Luitpold, Luitpold Pharms Inc, Lyphomed, Miles, Mylan Labs Ltd, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, G And W Labs Inc, Watson Labs Inc, Wockhardt, Paco, Vintage, Baxter Hlthcare, B Braun, Eastman Kodak, Empi, Fresenius Kabi Usa, and Actavis Mid Atlantic, and is included in one hundred and ten NDAs. It is available from thirty-five 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. Eleven suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.

Summary for 202346

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 202346

Ingredient-typeAmides
Physiological EffectLocal Anesthesia

Suppliers and Packaging for NDA: 202346

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIDOCAINE lidocaine PATCH;TOPICAL 202346 ANDA Mylan Pharmaceuticals Inc. 0378-9055 0378-9055-93 30 POUCH in 1 CARTON (0378-9055-93) > 1 PATCH in 1 POUCH (0378-9055-16)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:PATCH;TOPICALStrength5%
Approval Date:Aug 7, 2015TE:ABRLD:No


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