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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078432

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NDA 078432 describes NAPROXEN SODIUM, which is a drug marketed by Bionpharma Inc, Actavis Labs Fl Inc, Able, Amneal Pharms Ny, Aurobindo Pharma Ltd, Contract Pharmacal, Dr Reddys Labs Inc, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Granules India, Hamilton Pharms, Hikma, Ivax Sub Teva Pharms, Lnk Intl Inc, Marksans Pharma, Mylan, Perrigo, Pld Acquisitions Llc, Pliva, Purepac Pharm, Roxane, Sandoz, Sun Pharm Inds Ltd, Teva, Teva Pharms, and Watson Labs, and is included in thirty-four NDAs. It is available from one hundred and forty-five suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the NAPROXEN SODIUM profile page.

The generic ingredient in NAPROXEN SODIUM 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 078432
Tradename:NAPROXEN SODIUM
Applicant:Amneal Pharms Ny
Ingredient:naproxen sodium
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078432
Suppliers and Packaging for NDA: 078432
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPROXEN SODIUM naproxen sodium TABLET;ORAL 078432 ANDA Major Pharmaceuticals 0904-6185 N 0904-6185-40
NAPROXEN SODIUM naproxen sodium TABLET;ORAL 078432 ANDA Major Pharmaceuticals 0904-6186 N 0904-6186-40

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 250MG BASE
Approval Date:Apr 25, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 500MG BASE
Approval Date:Apr 25, 2007TE:ABRLD:No

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