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Serving 500+ biopharmaceutical companies globally:

Express Scripts
Colorcon
US Army
Farmers Insurance
Queensland Health
UBS
US Department of Justice
Merck
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Generated: June 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078314

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NDA 078314 describes NAPROXEN SODIUM, which is a drug marketed by Hamilton Pharms, Glenmark Pharms Ltd, 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, Granules India, Watson Labs, Roxane, Perrigo, Mylan, Dr Reddys Labs Inc, Lnk Intl Inc, Hikma, Sun Pharm Inds Ltd, Dr Reddys Labs Ltd, and Teva Pharms, and is included in thirty-four NDAs. It is available from one hundred and fifty-one suppliers. 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. Thirteen suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.

Summary for NDA: 078314

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

Pharmacology for NDA: 078314

Suppliers and Packaging for NDA: 078314

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPROXEN SODIUM
naproxen sodium
TABLET;ORAL 078314 ANDA Blenheim Pharmacal, Inc. 10544-063 10544-063-20 20 TABLET in 1 BOTTLE (10544-063-20)
NAPROXEN SODIUM
naproxen sodium
TABLET;ORAL 078314 ANDA Blenheim Pharmacal, Inc. 10544-275 10544-275-15 15 TABLET in 1 BOTTLE (10544-275-15)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Apr 27, 2007TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:Apr 27, 2007TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Federal Trade Commission
Accenture
Julphar
Johnson and Johnson
Citi
Medtronic
US Army
Cipla
McKinsey

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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