Application Nr Approved Date Route Status External Links
ANDA075227 1998-06-30 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 Dosage For The Shortest Duration Consistent With Individual Patient Treatment Goals (see Warnings:gastrointestinal Bleeding, Ulceration, And Perforation ). Naproxen Delayed-Release Tablets Are Indicated: 1.for The Relief Of The Signs And Symptoms Of Rheumatoid Arthritis 2.for The Relief Of The Signs And Symptoms Of Osteoarthritis 3.for The Relief Of The Signs And Symptoms Of Ankylosing Spondylitis 4.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 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, Dosage And Administration ).

All Formulated Excipients (8 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. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
6. Shellac SHELLAC Unresolved
7. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
8. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

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

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