Application Nr Approved Date Route Status External Links
ANDA074201 1993-12-21 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 Tablets Usp And Other Treatment Options Before Deciding To Use Naproxen Tablets Usp. Use The Lowest Effective Dose For The Shortest Duration Consistent With Individual Patient Treatment Goals (see Warnings). Naproxen Tablets Usp 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 Suspension Is Recommended For Juvenile Rheumatoid Arthritis In Order To Obtain The Maximum Dosage Flexibility Based On The Patient’s Weight. Naproxen Tablets Usp Are Also Indicated: For The Relief Of The Signs And Symptoms Of Tendonitis For The Relief Of The Signs And Symptoms Of Bursitis For The Relief Of The Signs And Symptoms Of Acute Gout For The Management Of Pain For The Management Of Primary Dysmenorrhea

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Starch, Corn STARCH, CORN Unresolved
2. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
3. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
4. Povidones POVIDONES Unresolved
5. Ferric Oxide Red FERRIC OXIDE RED Molecular

Active Ingredients ( 1 Total)

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

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