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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-four 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 list154
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
Pernix Ireland Ltd
TREXIMET
naproxen sodium; sumatriptan succinate
TABLET;ORAL021926-002May 14, 2015RXNo6,060,499*PED<disabled>Y<disabled>
Sandoz
NAPROXEN SODIUM
naproxen sodium
TABLET;ORAL074495-001Dec 5, 1994DISCNNo<disabled><disabled>
Alvogen Malta
NAPRELAN
naproxen sodium
TABLET, EXTENDED RELEASE;ORAL020353-001Jan 5, 1996RXNo<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
naproxen sodium
TABLET;ORAL018164-001Approved Prior to Jan 1, 19824,009,197<disabled>
Alvogen Malta
NAPRELAN
naproxen sodium
TABLET, EXTENDED RELEASE;ORAL020353-001Jan 5, 19965,637,320<disabled>
Alvogen Malta
NAPRELAN
naproxen sodium
TABLET, EXTENDED RELEASE;ORAL020353-003Jan 5, 19965,637,320<disabled>
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