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Details for New Drug Application (NDA): 080198

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NDA 080198 describes LIDOCAINE, which is a drug marketed by Belmora Llc, Septodont Inc, Teligent Pharma Inc, Taro, Mylan Technologies, Actavis Labs Ut Inc, Amneal Pharms, Fougera, Glenmark Pharms Ltd, Tolmar, Fougera Pharms, Hi Tech Pharma, Intl Medication, Roxane, Graham Chem, Eurohlth Intl Sarl, 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 six NDAs. It is available from twenty-nine suppliers. Additional details are available on the LIDOCAINE profile page.

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

Summary for NDA: 080198

Tradename:
LIDOCAINE
Applicant:
Fougera
Ingredient:
lidocaine
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 080198

Ingredient-typeAmides
Physiological EffectLocal Anesthesia

Suppliers and Packaging for NDA: 080198

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIDOCAINE
lidocaine
OINTMENT;TOPICAL 080198 ANDA E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. 0168-0204 0168-0204-37 1 TUBE in 1 CARTON (0168-0204-37) > 35.44 g in 1 TUBE
LIDOCAINE
lidocaine
OINTMENT;TOPICAL 080198 ANDA Rebel Distributors Corp 21695-826 21695-826-35 35 g in 1 TUBE (21695-826-35)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength5%
Approval Date:Approved Prior to Jan 1, 1982TE:ATRLD:Yes


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