Naproxen sodium is the generic ingredient in eight branded drugs marketed by Banner Pharmacaps, 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, Ranbaxy Labs Ltd, Roxane, Sandoz, Teva, Teva Pharms, Watson Labs, and Pernix Ireland Ltd, and is included in thirty-seven NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.
There are fourty-two drug master file entries for naproxen sodium. Fifty-six suppliers are listed for this compound.
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Type||RLD||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|TABLET;ORAL||074646||Jan 13, 1997||DISCN||No||<disabled>||<disabled>|
|TABLET;ORAL||074480||Feb 18, 1998||RX||No||<disabled>||<disabled>|
Ivax Sub Teva Pharms
|TABLET;ORAL||074230||Mar 14, 1995||DISCN||No||<disabled>||<disabled>|
Pernix Ireland Ltd
naproxen sodium; sumatriptan succinate
|TABLET;ORAL||021926||Apr 15, 2008||RX||Yes||8,022,095||<disabled>||Y||<disabled>|
Dr Reddys Labs Inc
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE
naproxen sodium; pseudoephedrine hydrochloride
|TABLET, EXTENDED RELEASE;ORAL||077381||Sep 27, 2006||OTC||No||<disabled>||<disabled>|
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