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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 204872


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NDA 204872 describes NAPROXEN SODIUM, which is a drug marketed by Bionpharma, Catalent, Patheon Softgels, Puracap Pharm Llc, Strides Pharma, 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, Hetero Labs Ltd V, Hikma, Ivax Sub Teva Pharms, Lnk Intl Inc, Marksans Pharma, Norvium Bioscience, 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, Corepharma, Granules, P And L, Perrigo R And D, and Aurobindo Pharma, and is included in forty-eight NDAs. It is available from one hundred and twenty-three suppliers. There are five 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. Ten suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.
Summary for 204872
Tradename:NAPROXEN SODIUM
Applicant:Lnk Intl Inc
Ingredient:naproxen sodium
Patents:0
Pharmacology for NDA: 204872
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 204872
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPROXEN SODIUM naproxen sodium TABLET;ORAL 204872 ANDA Rite Aid Corporation 11822-4170 11822-4170-5 1 BOTTLE, PLASTIC in 1 CARTON (11822-4170-5) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
NAPROXEN SODIUM naproxen sodium TABLET;ORAL 204872 ANDA Rite Aid Corporation 11822-4171 11822-4171-2 1 BOTTLE, PLASTIC in 1 CARTON (11822-4171-2) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength220MG
Approval Date:Jan 23, 2017TE:RLD:No

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