Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 9, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040014

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NDA 040014 describes LIDOCAINE HYDROCHLORIDE, which is a drug marketed by Abbott, Abraxis Pharm, Akorn, Aurobindo Pharma Ltd, B Braun Medical Inc, Bel Mar, Belmora Llc, Dell Labs, Elkins Sinn, Fresenius Kabi Usa, Gd Searle Llc, Hospira, Intl Medication, Luitpold, Lyphomed, Miles, Mylan Labs Ltd, Spectra Mdcl Devices, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Acp Nimble, Watson Labs Inc, Hi Tech Pharma, Wockhardt Bio Ag, Lannett Co Inc, Paco, Teligent Pharma Inc, Baxter Hlthcare, B Braun, Eastman Kodak, Empi, and Actavis Mid Atlantic, and is included in ninety-six NDAs. It is available from twenty-seven suppliers. Additional details are available on the LIDOCAINE HYDROCHLORIDE profile page.

The generic ingredient in LIDOCAINE HYDROCHLORIDE is epinephrine; lidocaine hydrochloride. There are twenty-one drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.
Summary for 040014
Tradename:LIDOCAINE HYDROCHLORIDE
Applicant:Hi Tech Pharma
Ingredient:lidocaine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040014
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 040014
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride SOLUTION;ORAL 040014 ANDA Atlantic Biologicals Corps 17856-0775 17856-0775-1 10 mL in 1 CUP (17856-0775-1)
LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride SOLUTION;ORAL 040014 ANDA Atlantic Biologicals Corps 17856-0775 17856-0775-2 20 mL in 1 CUP (17856-0775-2)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength2%
Approval Date:Jul 10, 1995TE:ATRLD:No

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