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Serving leading biopharmaceutical companies globally:

Accenture
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Federal Trade Commission
Chubb
Colorcon
Merck
Express Scripts
Fish and Richardson
Baxter
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Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074190

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NDA 074190 describes NAPROXEN, which is a drug marketed by West-ward Pharms Int, Actavis Elizabeth, Invagen Pharms, Mylan Pharms Inc, Pliva, Sandoz, 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, and Sun Pharm Inds Ltd, and is included in sixty-five NDAs. It is available from sixty-eight 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 074190
Tradename:NAPROXEN
Applicant:West-ward Pharms Int
Ingredient:naproxen
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 074190
Medical Subject Heading (MeSH) Categories for 074190
Suppliers and Packaging for NDA: 074190
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPROXEN naproxen SUSPENSION;ORAL 074190 ANDA Palmetto Pharmaceuticals 68134-201 68134-201-16 500 mL in 1 BOTTLE, PLASTIC (68134-201-16)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength25MG/ML
Approval Date:Mar 30, 1994TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Medtronic
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QuintilesIMS
Chinese Patent Office
US Army
Teva
Federal Trade Commission
Boehringer Ingelheim

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.

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