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Details for New Drug Application (NDA): 075927

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NDA 075927 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: 075927

Tradename:
NAPROXEN
Applicant:
Amneal Pharms Ny
Ingredient:
naproxen
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075927

Suppliers and Packaging for NDA: 075927

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPROXEN
naproxen
TABLET;ORAL 075927 ANDA Liberty Pharmaceuticals, Inc. 0440-1852 0440-1852-60 60 TABLET in 1 BOTTLE, PLASTIC (0440-1852-60)
NAPROXEN
naproxen
TABLET;ORAL 075927 ANDA Liberty Pharmaceuticals, Inc. 0440-7852 0440-7852-14 14 TABLET in 1 BOTTLE (0440-7852-14)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Dec 18, 2001TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength375MG
Approval Date:Dec 18, 2001TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Dec 18, 2001TE:ABRLD:No


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