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Serving leading biopharmaceutical companies globally:

Fuji
Express Scripts
Dow
Daiichi Sankyo
Cerilliant
AstraZeneca
Baxter
Boehringer Ingelheim
Mallinckrodt
Healthtrust

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021920

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NDA 021920 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, 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-four 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 021920
Tradename:NAPROXEN SODIUM
Applicant:Bionpharma Inc
Ingredient:naproxen sodium
Patents:2
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 021920
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPROXEN SODIUM naproxen sodium CAPSULE;ORAL 021920 NDA Bayer HealthCare LLC. 0280-6080 0280-6080-80 1 BOTTLE, PLASTIC in 1 CARTON (0280-6080-80) > 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
NAPROXEN SODIUM naproxen sodium CAPSULE;ORAL 021920 NDA Bayer HealthCare LLC. 0280-6080 0280-6080-20 1 BOTTLE, PLASTIC in 1 CARTON (0280-6080-20) > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CAPSULE;ORALStrengthEQ 200MG BASE
Approval Date:Feb 17, 2006TE:RLD:Yes
Patent:➤ SubscribePatent Expiration:Mar 3, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:➤ SubscribePatent Expiration:Mar 3, 2026Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Argus Health
US Department of Justice
Fuji
Boehringer Ingelheim
Chinese Patent Office
Mallinckrodt
McKesson
Healthtrust

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