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Last Updated: January 23, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020533

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NDA 020533 describes NAROPIN, which is a drug marketed by Fresenius Kabi Usa and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug and three Paragraph IV challenges. Additional details are available on the NAROPIN profile page.

The generic ingredient in NAROPIN is ropivacaine hydrochloride. There are thirteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the ropivacaine hydrochloride profile page.
Summary for 020533
Tradename:NAROPIN
Applicant:Fresenius Kabi Usa
Ingredient:ropivacaine hydrochloride
Patents:4
Formulation / Manufacturing:see details
Pharmacology for NDA: 020533
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 020533
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533 NDA General Injectables & Vaccines, Inc 52584-286 52584-286-35 1 VIAL, SINGLE-DOSE in 1 BAG (52584-286-35) > 30 mL in 1 VIAL, SINGLE-DOSE
NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533 NDA Fresenius Kabi USA, LLC 63323-285 63323-285-67 12 BOTTLE in 1 CASE (63323-285-67) > 100 mL in 1 BOTTLE (63323-285-55)
Paragraph IV (Patent) Challenges for 020533
Tradename Dosage Ingredient NDA Submissiondate
NAROPIN SOLUTION;INJECTION ropivacaine hydrochloride 020533 2015-09-03
NAROPIN SOLUTION;INJECTION ropivacaine hydrochloride 020533 2015-01-30
NAROPIN SOLUTION;INJECTION ropivacaine hydrochloride 020533 2006-11-13

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTIONStrength20MG/10ML (2MG/ML)
Approval Date:May 1, 1998TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTIONStrength40MG/20ML (2MG/ML)
Approval Date:Sep 24, 1996TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INJECTIONStrength100MG/20ML (5MG/ML)
Approval Date:May 1, 1998TE:APRLD:Yes

Expired US Patents for NDA 020533

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-003 May 1, 1998   Start Trial   Start Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-005 Sep 24, 1996   Start Trial   Start Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-001 May 1, 1998   Start Trial   Start Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-003 May 1, 1998   Start Trial   Start Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-004 Sep 24, 1996   Start Trial   Start Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-004 Sep 24, 1996   Start Trial   Start Trial
Fresenius Kabi Usa NAROPIN ropivacaine hydrochloride SOLUTION;INJECTION 020533-005 Sep 24, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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