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Generated: September 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076494

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NDA 076494 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: 076494

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

Pharmacology for NDA: 076494

Suppliers and Packaging for NDA: 076494

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPROXEN
naproxen
TABLET;ORAL 076494 ANDA West-Ward Pharmaceuticals Corp 0143-1346 0143-1346-01 100 TABLET in 1 BOTTLE, PLASTIC (0143-1346-01)
NAPROXEN
naproxen
TABLET;ORAL 076494 ANDA West-Ward Pharmaceuticals Corp 0143-1346 0143-1346-05 500 TABLET in 1 BOTTLE, PLASTIC (0143-1346-05)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength250MG
Approval Date:Jan 14, 2004TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength375MG
Approval Date:Jan 14, 2004TE:RLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength500MG
Approval Date:Jan 14, 2004TE:RLD:No


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Fish and Richardson
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Dow
Covington
Healthtrust
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