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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 091353


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NDA 091353 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 091353
Tradename:NAPROXEN SODIUM
Applicant:Granules India
Ingredient:naproxen sodium
Patents:0
Pharmacology for NDA: 091353
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 091353
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPROXEN SODIUM naproxen sodium TABLET;ORAL 091353 ANDA TARGET CORPORATION 11673-764 11673-764-05 50 TABLET in 1 BOTTLE (11673-764-05)
NAPROXEN SODIUM naproxen sodium TABLET;ORAL 091353 ANDA TARGET CORPORATION 11673-764 11673-764-09 90 TABLET in 1 BOTTLE (11673-764-09)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength220MG
Approval Date:Sep 20, 2011TE:RLD:No

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