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Generated: July 22, 2017

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 Intl Medication, West-ward Pharms Int, Belmora Llc, Abraxis Pharm, Bel Mar, Vintage, Hospira, Miles, Hi Tech Pharma, 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, Teligent Pharma Inc, Baxter Hlthcare, B Braun, Eastman Kodak, Empi, Fresenius Kabi Usa, Aurobindo Pharma Ltd, and Actavis Mid Atlantic, and is included in ninety-three NDAs. It is available from twenty-nine 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 NDA: 080407

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
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)

Summary for product number 001

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

Summary 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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Serving 500+ biopharmaceutical companies globally:

Merck
Citi
Fuji
Farmers Insurance
Johnson and Johnson
QuintilesIMS
McKinsey
Moodys
US Army
Daiichi Sankyo

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