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Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203955

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NDA 203955 describes ROPIVACAINE HYDROCHLORIDE, which is a drug marketed by Akorn, Akorn Inc, Aurobindo Pharma Ltd, Hospira, Mylan Asi, and Navinta Llc, and is included in six NDAs. It is available from five suppliers. Additional details are available on the ROPIVACAINE HYDROCHLORIDE profile page.

The generic ingredient in ROPIVACAINE HYDROCHLORIDE is ropivacaine hydrochloride. There are thirteen drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ropivacaine hydrochloride profile page.
Summary for 203955
Applicant:Akorn Inc
Ingredient:ropivacaine hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 203955
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 203955
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 203955 ANDA Akorn, Inc. 17478-081 N 17478-081-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTIONStrength150MG/30ML (5MG/ML)
Approval Date:Apr 11, 2016TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Argus Health
Harvard Business School
Fish and Richardson
US Army

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