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Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075390

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NDA 075390 describes NAPROXEN, which is a drug marketed by Teva, Dava Pharms Inc, Invagen Pharms, Teva Pharms, Chartwell Molecules, Hamilton Pharms, Ivax Sub Teva Pharms, Roxane, Marksans Pharma, Zydus Pharms Usa, Mylan, Amneal Pharms Ny, Aurobindo Pharma Ltd, Actavis Elizabeth, Pliva, Perrigo R And D, Sandoz, Glenmark Generics, Watson Labs, Purepac Pharm, Watson Labs Teva, West-ward Pharms Int, Mylan Pharms Inc, Hikma Intl Pharms, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Actavis Labs Fl Inc, Bionpharma Inc, Contract Pharmacal, Able, Granules India, Perrigo, Dr Reddys Labs Inc, Lnk Intl Inc, Hikma, and Sun Pharm Inds Ltd, and is included in sixty-five NDAs. It is available from sixty-six suppliers. Additional details are available on the NAPROXEN profile page.

The generic ingredient in NAPROXEN 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: 075390

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

Pharmacology for NDA: 075390

Suppliers and Packaging for NDA: 075390

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPROXEN
naproxen
TABLET, DELAYED RELEASE;ORAL 075390 ANDA Physicians Total Care, Inc. 54868-4051 54868-4051-0 30 TABLET, DELAYED RELEASE in 1 BOTTLE (54868-4051-0)
NAPROXEN
naproxen
TABLET, DELAYED RELEASE;ORAL 075390 ANDA Physicians Total Care, Inc. 54868-4051 54868-4051-1 40 TABLET, DELAYED RELEASE in 1 BOTTLE (54868-4051-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength375MG
Approval Date:Apr 19, 2001TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength500MG
Approval Date:Apr 19, 2001TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Medtronic
Colorcon
Teva
Cipla
Federal Trade Commission
Merck
US Army
Queensland Health
AstraZeneca
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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