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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Generated: August 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207182

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NDA 207182 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 thirty-four 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. Twelve suppliers are listed for this compound. Additional details are available on the epinephrine; lidocaine hydrochloride profile page.
Summary for 207182
Tradename:LIDOCAINE HYDROCHLORIDE
Applicant:Aurobindo Pharma Ltd
Ingredient:lidocaine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207182
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 207182
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride INJECTABLE;INJECTION 207182 ANDA AuroMedics Pharma LLC 55150-251 55150-251-10 25 VIAL, MULTI-DOSE in 1 CARTON (55150-251-10) > 10 mL in 1 VIAL, MULTI-DOSE
LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride INJECTABLE;INJECTION 207182 ANDA AuroMedics Pharma LLC 55150-252 55150-252-20 25 VIAL, MULTI-DOSE in 1 CARTON (55150-252-20) > 20 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1%
Approval Date:Oct 30, 2017TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength2%
Approval Date:Oct 30, 2017TE:APRLD:No

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