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 Tablets Or Naproxen Sodium Tablets. Use The Lowest Effective Dosage For The Shortest Duration Consistent With Individual Patient Treatment Goals (see Warnings: Gastrointestinal Bleeding, Ulceration, And Perforation). 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 Tablets Or 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 (3 Total)

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

Active Ingredients ( 1 Total)

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

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