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Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091305

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NDA 091305 describes NAPROXEN, which is a drug marketed by West-ward Pharms Int, Actavis Elizabeth, Fosun Pharma, Invagen Pharms, Mylan Pharms Inc, Pliva, Teva, Amneal Pharms Ny, Aurobindo Pharma Ltd, Chartwell Molecules, Dava Pharms Inc, Glenmark Generics, Hamilton Pharms, Hikma Intl Pharms, Ivax Sub Teva Pharms, Marksans Pharma, Mylan, Perrigo R And D, Purepac Pharm, Roxane, Teva Pharms, Watson Labs, Watson Labs Teva, Zydus Pharms Usa, Dr Reddys Labs Ltd, Bionpharma Inc, Actavis Labs Fl Inc, Able, Contract Pharmacal, Dr Reddys Labs Inc, Glenmark Pharms Ltd, Granules India, Hikma, Lnk Intl Inc, Perrigo, Sandoz, and Sun Pharm Inds Ltd, and is included in sixty-four NDAs. It is available from sixty-eight suppliers. There are two patents protecting this drug and one Paragraph IV challenge. 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. Twelve suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.
Summary for 091305
Applicant:Invagen Pharms
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091305
Medical Subject Heading (MeSH) Categories for 091305
Suppliers and Packaging for NDA: 091305
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPROXEN naproxen TABLET;ORAL 091305 ANDA Blenheim Pharmacal, Inc. 10544-939 E 10544-939-30
NAPROXEN naproxen TABLET;ORAL 091305 ANDA Blenheim Pharmacal, Inc. 10544-939 E 10544-939-14

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Aug 24, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength375MG
Approval Date:Aug 24, 2011TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Aug 24, 2011TE:ABRLD:No

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