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Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091416

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NDA 091416 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 091416
Tradename:NAPROXEN
Applicant:Marksans Pharma
Ingredient:naproxen
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091416
Medical Subject Heading (MeSH) Categories for 091416
Suppliers and Packaging for NDA: 091416
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPROXEN naproxen TABLET;ORAL 091416 ANDA Major Pharmaceuticals 0904-6295 0904-6295-60 100 TABLET in 1 BOTTLE (0904-6295-60)
NAPROXEN naproxen TABLET;ORAL 091416 ANDA Major Pharmaceuticals 0904-6295 0904-6295-61 100 TABLET in 1 BOX, UNIT-DOSE (0904-6295-61)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Feb 14, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength375MG
Approval Date:Feb 14, 2011TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Feb 14, 2011TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Mallinckrodt
QuintilesIMS
AstraZeneca
Federal Trade Commission
Novartis
Merck
Moodys
US Department of Justice

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