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Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079096

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NDA 079096 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 079096

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

Pharmacology for NDA: 079096

Suppliers and Packaging for NDA: 079096

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPROXEN SODIUM naproxen sodium TABLET;ORAL 079096 ANDA Walgreens 0363-0168 0363-0168-01 1 BOTTLE, PLASTIC in 1 BOX (0363-0168-01) > 100 TABLET in 1 BOTTLE, PLASTIC
NAPROXEN SODIUM naproxen sodium TABLET;ORAL 079096 ANDA Walgreens 0363-0168 0363-0168-24 1 BOTTLE, PLASTIC in 1 BOX (0363-0168-24) > 24 TABLET in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrengthEQ 200MG BASE
Approval Date:Dec 16, 2008TE:RLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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