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Generated: December 11, 2018

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Details for New Drug Application (NDA): 074106

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NDA 074106 describes NAPROXEN SODIUM, which is a drug marketed by Bionpharma Inc, Puracap Pharm Llc, Actavis Labs Fl Inc, Able, Amneal Pharms Ny, Aurobindo Pharma Ltd, Contract Pharmacal, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Granules India, Hamilton Pharms, Hikma, Ivax Sub Teva Pharms, Lnk Intl Inc, Marksans Pharma, Mylan, Perrigo, Pld Acquisitions Llc, Pliva, Purepac Pharm, Roxane, Sandoz, Sun Pharm Inds Ltd, Teva, Teva Pharms, Watson Labs, and Amneal Pharms Co, and is included in thirty-six NDAs. It is available from one hundred and fifty suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the NAPROXEN SODIUM profile page.

The generic ingredient in NAPROXEN SODIUM is naproxen sodium; pseudoephedrine hydrochloride. There are forty-two drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.
Summary for 074106
Tradename:NAPROXEN SODIUM
Applicant:Hamilton Pharms
Ingredient:naproxen sodium
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Aug 31, 1993TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:Aug 31, 1993TE:RLD:No

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