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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 075416


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NDA 075416 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, 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, 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-seven 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. Eight suppliers are listed for this compound. Additional details are available on the naproxen sodium; pseudoephedrine hydrochloride profile page.
Summary for 075416
Tradename:NAPROXEN SODIUM
Applicant:Actavis Labs Fl Inc
Ingredient:naproxen sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075416
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 075416
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NAPROXEN SODIUM naproxen sodium TABLET, EXTENDED RELEASE;ORAL 075416 ANDA Teva Pharmaceuticals, Inc. 0480-0951 0480-0951-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0480-0951-01)
NAPROXEN SODIUM naproxen sodium TABLET, EXTENDED RELEASE;ORAL 075416 ANDA Teva Pharmaceuticals, Inc. 0480-0952 0480-0952-58 75 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0480-0952-58)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 500MG BASE
Approval Date:Aug 27, 2002TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 375MG BASE
Approval Date:Apr 23, 2003TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 750MG BASE
Approval Date:Aug 11, 2016TE:ABRLD:No

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