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Details for Generic Name: naproxen sodium

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Naproxen sodium is the generic ingredient in eight branded drugs marketed by Banner Life Sciences, Catalent, Almatica Pharma Inc, Actavis Labs Fl Inc, Bayer, Hoffmann La Roche, Able, Amneal Pharms Ny, Aurobindo Pharma Ltd, Contract Pharmacal, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Glenmark Generics, Granules India, Hamilton Pharms, Hikma, Ivax Sub Teva Pharms, Marksans Pharma, Mylan, Perrigo, Pliva, Purepac Pharm, Roxane, Sandoz, Sun Pharm Inds Ltd, Teva, Teva Pharms, Watson Labs, and Pernix Ireland Ltd, and is included in thirty-eight NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are forty-two drug master file entries for naproxen sodium. Fifty-eight suppliers are listed for this compound.

Summary for Generic Name: naproxen sodium

Drug Master File Entries: see list42
Suppliers / Packaging: see list182
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: naproxen sodium

Clinical Trials for: naproxen sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms Ny
naproxen sodium
TABLET;ORAL078432-002Apr 25, 2007RXNo<disabled><disabled>
naproxen sodium
TABLET;ORAL074646-001Jan 13, 1997DISCNNo<disabled><disabled>
Ivax Sub Teva Pharms
naproxen sodium
TABLET;ORAL074230-002Mar 14, 1995DISCNNo<disabled><disabled>
Marksans Pharma
naproxen sodium
TABLET;ORAL090545-001Mar 16, 2011OTCNo<disabled><disabled>
Sun Pharm Inds Ltd
naproxen sodium
TABLET;ORAL091183-001May 20, 2011OTCNo<disabled><disabled>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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