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Naproxen sodium - Generic Drug Details

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Naproxen sodium is the generic ingredient in eight branded drugs marketed by Bayer, Hamilton Pharms, Glenmark Generics, Actavis Labs Fl Inc, Purepac Pharm, Bionpharma Inc, Aurobindo Pharma Ltd, Ivax Sub Teva Pharms, Amneal Pharms Ny, Contract Pharmacal, Pliva, Teva, Able, Marksans Pharma, Sandoz, Alvogen Malta, Granules India, Watson Labs, Roxane, Perrigo, Atnahs Pharma Us, Mylan, Dr Reddys Labs Inc, Hikma, Sun Pharm Inds Ltd, Dr Reddys Labs Ltd, Teva Pharms, and Pernix Ireland Ltd, and is included in thirty-eight NDAs. There are five 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. One hundred and fifty-five suppliers are listed for this compound.

Summary for Generic Name: naproxen sodium

Tradenames:8
Patents:5
Applicants:28
NDAs:38
Drug Master File Entries: see list42
Suppliers / Packaging: see list155
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
Teva Pharms
NAPROXEN SODIUM
naproxen sodium
TABLET;ORAL074289-002Jan 27, 1994DISCNNo<disabled><disabled>
Aurobindo Pharma Ltd
NAPROXEN SODIUM
naproxen sodium
TABLET;ORAL200629-001Oct 31, 2011RXNo<disabled><disabled>
Dr Reddys Labs Inc
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE
naproxen sodium; pseudoephedrine hydrochloride
TABLET, EXTENDED RELEASE;ORAL077381-001Sep 27, 2006OTCNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: naproxen sodium

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Atnahs Pharma Us
ANAPROX DS
naproxen sodium
TABLET;ORAL018164-003Sep 30, 19874,001,301<disabled>
Atnahs Pharma Us
ANAPROX DS
naproxen sodium
TABLET;ORAL018164-003Sep 30, 19873,998,966<disabled>
Alvogen Malta
NAPRELAN
naproxen sodium
TABLET, EXTENDED RELEASE;ORAL020353-001Jan 5, 19965,637,320<disabled>
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