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Last Updated: November 22, 2019

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, Catalent, Puracap Pharm Llc, 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, Novelgenix Theraps, Perrigo, Pld Acquisitions Llc, Pliva, Purepac Pharm, Roxane, Sandoz, Sun Pharm Inds Ltd, Teva, Teva Pharms, Watson Labs, Yichang Humanwell, Amneal Pharms Co, Apotex Inc, P And L, and Perrigo R And D, and is included in forty-two NDAs. It is available from one hundred and thirty suppliers. There are four 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:4
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 0280-6080-16 160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0280-6080-16)
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
Paragraph IV (Patent) Challenges for 021920
Tradename Dosage Ingredient NDA Submissiondate
NAPROXEN SODIUM CAPSULE;ORAL naproxen sodium 021920 2017-11-15

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CAPSULE;ORALStrengthEQ 200MG BASE
Approval Date:Feb 17, 2006TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Mar 3, 2026Product Flag?YSubstance Flag?Delist Request?
Patented Use:TEMPORARY REDUCTION OF FEVER
Patent:  Start TrialPatent Expiration:Mar 3, 2026Product Flag?YSubstance Flag?Delist Request?
Patented Use:TEMPORARY RELIEF OF MINOR ACHES AND PAINS
Patent:  Start TrialPatent Expiration:Mar 3, 2026Product Flag?YSubstance Flag?Delist Request?
Patented Use:TEMPORARY REDUCTION OF FEVER

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