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

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Dow
Teva
Boehringer Ingelheim
Chinese Patent Office
Healthtrust
US Army
Farmers Insurance
Express Scripts
Deloitte

Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075416

« Back to Dashboard

NDA 075416 describes NAPROXEN SODIUM, which is a drug marketed by Bionpharma Inc, Actavis Labs Fl Inc, Able, Amneal Pharms Ny, Aurobindo Pharma Ltd, Contract Pharmacal, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Granules India, Hamilton Pharms, Hikma, Ivax Sub Teva Pharms, Lnk Intl Inc, Marksans Pharma, Mylan, Perrigo, Pliva, Purepac Pharm, Roxane, Sandoz, Sun Pharm Inds Ltd, Teva, Teva Pharms, and Watson Labs, and is included in thirty-four NDAs. It is available from one hundred and forty-two suppliers. There are two patents protecting this drug. Additional details are available on the NAPROXEN SODIUM profile page.

The generic ingredient in NAPROXEN SODIUM is naproxen sodium; pseudoephedrine hydrochloride. There are forty-two drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.

Summary for 075416

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075416

Suppliers and Packaging for NDA: 075416

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPROXEN SODIUM naproxen sodium TABLET, EXTENDED RELEASE;ORAL 075416 ANDA Actavis Pharma, Inc. 62037-825 62037-825-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62037-825-01)
NAPROXEN SODIUM naproxen sodium TABLET, EXTENDED RELEASE;ORAL 075416 ANDA Actavis Pharma, Inc. 62037-826 62037-826-75 75 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62037-826-75)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 500MG BASE
Approval Date:Aug 27, 2002TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 375MG BASE
Approval Date:Apr 23, 2003TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 750MG BASE
Approval Date:Aug 11, 2016TE:ABRLD:No


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:

QuintilesIMS
Moodys
US Department of Justice
Harvard Business School
Healthtrust
McKesson
Accenture
Johnson and Johnson
Cipla
Medtronic

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:

botpot