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McKesson
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Mallinckrodt
Colorcon
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Generated: June 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090318

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NDA 090318 describes ROPIVACAINE HYDROCHLORIDE, which is a drug marketed by Akorn, Akorn Inc, Aurobindo Pharma Ltd, Hospira, Inforlife, Mylan Asi, and Navinta Llc, and is included in seven 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 090318
Tradename:ROPIVACAINE HYDROCHLORIDE
Applicant:Mylan Asi
Ingredient:ropivacaine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090318
Ingredient-typeAmides
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 090318
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 090318 ANDA Sagent Pharmaceuticals 25021-652 N 25021-652-30
ROPIVACAINE HYDROCHLORIDE ropivacaine hydrochloride SOLUTION;INJECTION 090318 ANDA Sagent Pharmaceuticals 25021-652 N 25021-652-31

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTIONStrength40MG/20ML (2MG/ML)
Approval Date:Sep 23, 2014TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTIONStrength150MG/30ML (5MG/ML)
Approval Date:Sep 23, 2014TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTIONStrength150MG/20ML (7.5MG/ML)
Approval Date:Sep 23, 2014TE:APRLD:No

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