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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, Hamilton Pharms, Ivax Sub Teva Pharms, Roxane, Marksans Pharma, Zydus Pharms Usa, Mylan, Amneal Pharms Ny, Aurobindo Pharma Usa, Actavis Elizabeth, Pliva, Perrigo R And D, Sandoz, Glenmark Generics, Watson Labs, Purepac Pharm, Mylan Pharms Inc, Hikma Intl Pharms, Dr Reddys Labs Ltd, Actavis Labs Fl Inc, Bionpharma Inc, Aurobindo Pharma Ltd, Contract Pharmacal, Able, Granules India, Perrigo, Dr Reddys Labs Inc, Hikma, and Sun Pharm Inds Ltd, and is included in sixty-four NDAs. It is available from sixty-five 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:
NAPROXEN
Applicant:
Mylan Pharms Inc
Ingredient:
naproxen
Patents:0
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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