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Last Updated: August 1, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208363


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NDA 208363 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, Sciegen Pharms Inc, Sun Pharm Inds Ltd, Teva, Teva Pharms, Watson Labs, Yichang Humanwell, Amneal Pharms Co, Apotex, Granules, P And L, and Perrigo R And D, and is included in forty-four NDAs. It is available from one hundred and seventeen 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. Seven suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.
Summary for 208363
Tradename:NAPROXEN SODIUM
Applicant:Puracap Pharm Llc
Ingredient:naproxen sodium
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 208363
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPROXEN SODIUM naproxen sodium CAPSULE;ORAL 208363 ANDA Walgreens 0363-0748 0363-0748-08 1 BOTTLE, PLASTIC in 1 BOX (0363-0748-08) > 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
NAPROXEN SODIUM naproxen sodium CAPSULE;ORAL 208363 ANDA Walgreens 0363-0748 0363-0748-12 1 BOTTLE, PLASTIC in 1 BOX (0363-0748-12) > 120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CAPSULE;ORALStrengthEQ 200MG BASE
Approval Date:Mar 15, 2018TE:RLD:No

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