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Serving leading biopharmaceutical companies globally:

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Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 080407

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NDA 080407 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 080407
Tradename:LIDOCAINE HYDROCHLORIDE
Applicant:West-ward Pharms Int
Ingredient:lidocaine hydrochloride
Patents:0
Therapeutic Class:Anesthetics
Formulation / Manufacturing:see details
Pharmacology for NDA: 080407
Ingredient-typeAmides
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 080407
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride INJECTABLE;INJECTION 080407 ANDA West-Ward Pharmaceuticals Corp 0143-9575 0143-9575-10 10 VIAL, MULTI-DOSE in 1 PACKAGE (0143-9575-10) > 50 mL in 1 VIAL, MULTI-DOSE (0143-9575-01)
LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride INJECTABLE;INJECTION 080407 ANDA West-Ward Pharmaceuticals Corp 0143-9576 0143-9576-25 25 VIAL, MULTI-DOSE in 1 PACKAGE (0143-9576-25) > 2 mL in 1 VIAL, MULTI-DOSE (0143-9576-01)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength1%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength2%
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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Chinese Patent Office
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US Army
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Novartis
AstraZeneca
Cipla
US Department of Justice

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