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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Express Scripts
Cantor Fitzgerald

Generated: June 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075390

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NDA 075390 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 sixty-nine 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 075390
Applicant:Mylan Pharms Inc
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075390
Medical Subject Heading (MeSH) Categories for 075390
Suppliers and Packaging for NDA: 075390
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPROXEN naproxen TABLET, DELAYED RELEASE;ORAL 075390 ANDA Physicians Total Care, Inc. 54868-4051 E 54868-4051-0
NAPROXEN naproxen TABLET, DELAYED RELEASE;ORAL 075390 ANDA Physicians Total Care, Inc. 54868-4051 E 54868-4051-1

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, DELAYED RELEASE;ORALStrength375MG
Approval Date:Apr 19, 2001TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, DELAYED RELEASE;ORALStrength500MG
Approval Date:Apr 19, 2001TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Army

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