Application Nr Approved Date Route Status External Links
ANDA078250 2007-03-28 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Carefully Consider The Potential Benefits And Risks Of Naproxen, Naproxen Sodium And Other Treatment Options Before Deciding To Use Naproxen Or Naproxen Sodium Tablets. Use The Lowest Effective Dose For The Shortest Duration Consistent With Individual Patient Treatment Goals (see Warnings ). Naproxen As Naproxen Tablets Or Naproxen Sodium Tablets Are Indicated: For The Relief Of The Signs And Symptoms Of Rheumatoid Arthritis For The Relief Of The Signs And Symptoms Of Osteoarthritis For The Relief Of The Signs And Symptoms Of Ankylosing Spondylitis For The Relief Of The Signs And Symptoms Of Juvenile Arthritis Naproxen As Naproxen Suspension Is Recommended For Juvenile Rheumatoid Arthritis In Order To Obtain The Maximum Dosage Flexibility Based On The Patient’s Weight. Naproxen As Naproxen Tablets And Naproxen Sodium Tablets Are Also Indicated: For Relief Of The Signs And Symptoms Of Tendonitis For Relief Of The Signs And Symptoms Of Bursitis For Relief Of The Signs And Symptoms Of Acute Gout For The Management Of Pain For The Management Of Primary Dysmenorrhea

All Formulated Excipients (2 Total)

Name Structure Kind Function Status
1. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
2. Ferric Oxide Red FERRIC OXIDE RED Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Naproxen NAPROXEN ZINC105216

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