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Details for New Drug Application (NDA): 206297

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NDA 206297 describes LIDOCAINE, which is a drug marketed by Alkem Labs Ltd, Belmora Llc, Septodont Inc, Teligent Pharma Inc, Taro, Mylan Technologies, Actavis Labs Ut Inc, Amneal Pharms, Fougera Pharms Inc, Glenmark Pharms Ltd, Tolmar, Fougera Pharms, Hi Tech Pharma, Intl Medication, West-ward Pharms Int, Abraxis Pharm, Bel Mar, Vintage, Hospira, Miles, 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, Baxter Hlthcare, B Braun, Eurohlth Intl Sarl, Eastman Kodak, Empi, Fresenius Kabi Usa, Aurobindo Pharma Ltd, and Actavis Mid Atlantic, and is included in one hundred and seven NDAs. It is available from twenty-nine suppliers. Additional details are available on the LIDOCAINE profile page.

The generic ingredient in LIDOCAINE is epinephrine; lidocaine hydrochloride. There are nineteen 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 NDA: 206297

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 206297

Ingredient-typeAmides
Physiological EffectLocal Anesthesia

Suppliers and Packaging for NDA: 206297

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LIDOCAINE
lidocaine
OINTMENT;TOPICAL 206297 ANDA AvKARE, Inc. 42291-379 42291-379-05 50 g in 1 JAR (42291-379-05)
LIDOCAINE
lidocaine
OINTMENT;TOPICAL 206297 ANDA AvKARE, Inc. 42291-379 42291-379-35 1 TUBE in 1 CARTON (42291-379-35) > 35.44 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength5%
Approval Date:Aug 7, 2015TE:ATRLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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