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Generated: August 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075227

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NDA 075227 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: 075227

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

Pharmacology for NDA: 075227

Suppliers and Packaging for NDA: 075227

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPROXEN
naproxen
TABLET, DELAYED RELEASE;ORAL 075227 ANDA Teva Pharmaceuticals USA, Inc. 0093-1005 0093-1005-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE (0093-1005-01)
NAPROXEN
naproxen
TABLET, DELAYED RELEASE;ORAL 075227 ANDA Teva Pharmaceuticals USA, Inc. 0093-1005 0093-1005-05 500 TABLET, DELAYED RELEASE in 1 BOTTLE (0093-1005-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength375MG
Approval Date:Jun 30, 1998TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength500MG
Approval Date:Jun 30, 1998TE:ABRLD:No


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