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

Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Fuji
Johnson and Johnson
US Army
Baxter
Fish and Richardson
Colorcon
Daiichi Sankyo
Queensland Health

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078250

« Back to Dashboard

NDA 078250 describes NAPROXEN, which is a drug marketed by West-ward Pharms Int, Actavis Elizabeth, Fosun Pharma, Invagen Pharms, Mylan Pharms Inc, Pliva, Teva, Amneal Pharms Ny, Aurobindo Pharma Ltd, Chartwell Molecules, Dava Pharms Inc, Glenmark Generics, Hamilton Pharms, Hikma Intl Pharms, Ivax Sub Teva Pharms, Marksans Pharma, Mylan, Perrigo R And D, Purepac Pharm, Roxane, Teva Pharms, Watson Labs, Watson Labs Teva, Zydus Pharms Usa, Dr Reddys Labs Ltd, Bionpharma Inc, Actavis Labs Fl Inc, Able, Contract Pharmacal, Dr Reddys Labs Inc, Glenmark Pharms Ltd, Granules India, Hikma, Lnk Intl Inc, Perrigo, Pld Acquisitions Llc, Sandoz, and Sun Pharm Inds Ltd, and is included in sixty-five NDAs. It is available from fifty-four suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the NAPROXEN profile page.

The generic ingredient in NAPROXEN 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 078250
Tradename:NAPROXEN
Applicant:Glenmark Generics
Ingredient:naproxen
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078250
Medical Subject Heading (MeSH) Categories for 078250
Suppliers and Packaging for NDA: 078250
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPROXEN naproxen TABLET;ORAL 078250 ANDA KAISER FOUNDATION HOSPITALS 0179-1978 N 0179-1978-50
NAPROXEN naproxen TABLET;ORAL 078250 ANDA KAISER FOUNDATION HOSPITALS 0179-1978 N 0179-1978-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Mar 28, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength375MG
Approval Date:Mar 28, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Mar 28, 2007TE:ABRLD:No

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Deloitte
Fuji
Citi
UBS
US Department of Justice
Express Scripts
Teva
Daiichi Sankyo

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.