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Last Updated: May 20, 2022

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 three 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 Effect Local 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 Henry Schein, Inc. 0404-9924 0404-9924-30 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9924-30) > 30 mL in 1 VIAL, SINGLE-DOSE
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

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

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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 verification 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.