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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 088328

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NDA 088328 describes LIDOCAINE HYDROCHLORIDE, which is a drug marketed by Abbott, Abraxis Pharm, Akorn, Aurobindo Pharma Ltd, Bel Mar, Belmora Llc, 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, Hi Tech Pharma, Wockhardt, Paco, Teligent Pharma Inc, Vintage, Baxter Hlthcare, B Braun, Eastman Kodak, Empi, Fresenius Kabi Usa, and Actavis Mid Atlantic, and is included in ninety-four NDAs. It is available from thirty suppliers. Additional details are available on the LIDOCAINE HYDROCHLORIDE profile page.

The generic ingredient in LIDOCAINE HYDROCHLORIDE 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 088328

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

Pharmacology for NDA: 088328

Ingredient-typeAmides
Physiological EffectLocal Anesthesia

Suppliers and Packaging for NDA: 088328

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride INJECTABLE;INJECTION 088328 ANDA Hospira, Inc. 0409-4278 0409-4278-01 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-4278-01) > 50 mL in 1 VIAL, SINGLE-DOSE (0409-4278-16)
LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride INJECTABLE;INJECTION 088328 ANDA Cardinal Health 55154-6984 55154-6984-8 1 AMPULE in 1 BAG (55154-6984-8) > 50 mL in 1 AMPULE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.5%
Approval Date:May 17, 1984TE:APRLD:No


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