Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Accenture
Cipla
Deloitte
Colorcon
Federal Trade Commission
Express Scripts
Teva
Boehringer Ingelheim
Cerilliant
Fish and Richardson

Generated: October 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020533

« Back to Dashboard
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. Eight suppliers are listed for this compound. Additional details are available on the ropivacaine hydrochloride profile page.

Summary for NDA: 020533

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:4
Formulation / Manufacturing:see details

Pharmacology for NDA: 020533

Ingredient-typeAmides
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 63323-285-10 5 BLISTER PACK in 1 BOX (63323-285-10) > 1 AMPULE in 1 BLISTER PACK > 10 mL in 1 AMPULE

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

Expired Orange Book Patents for NDA: 020533



Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Chubb
Cipla
McKesson
Cerilliant
Merck
Citi
Colorcon
Moodys
Covington

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot