Application Nr Approved Date Route Status External Links
ANDA091432 2011-09-19 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 Delayed-Release Tablets And Other Treatment Options Before Deciding To Use Naproxen Delayed-Release Tablets. Use The Lowest Effective Dose For The Shortest Duration Consistent With Individual Patient Treatment Goals (see Warnings). Naproxen Delayed-Release 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 Delayed-Release Tablets Are Not Recommended For Initial Treatment Of Acute Pain Because The Absorption Of Naproxen Is Delayed Compared To Absorption From Other Naproxen-Containing Products (see Clinical Pharmacology And Dosage And Administration).

All Formulated Excipients (1 Total)

Name Structure Kind Function Status
1. Povidones POVIDONES Unresolved

Active Ingredients ( 1 Total)

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

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