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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205497

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NDA 205497 describes NAPROXEN SODIUM, which is a drug marketed by Bionpharma Inc, 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, Pliva, Purepac Pharm, Roxane, Sandoz, Sun Pharm Inds Ltd, Teva, Teva Pharms, and Watson Labs, and is included in thirty-four NDAs. It is available from one hundred and forty-two suppliers. There are two patents protecting this drug. 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. Twelve suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.

Summary for 205497

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 205497

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPROXEN SODIUM naproxen sodium TABLET;ORAL 205497 ANDA Aurohealth LLC 58602-738 58602-738-07 1 BOTTLE in 1 CARTON (58602-738-07) > 24 TABLET, FILM COATED in 1 BOTTLE
NAPROXEN SODIUM naproxen sodium TABLET;ORAL 205497 ANDA Aurohealth LLC 58602-738 58602-738-29 1 BOTTLE in 1 CARTON (58602-738-29) > 150 TABLET, FILM COATED in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrengthEQ 200MG BASE
Approval Date:Mar 18, 2016TE:RLD:No


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