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

1 Indications And Usage Naproxen Delayed-Release Tablets Are Indicated For: The Relief Of The Signs And Symptoms Of: Rheumatoid Arthritis Osteoarthritis Ankylosing Spondylitis Polyarticular Juvenile Idiopathic Arthritis Naproxen Delayed-Release Tablets Are Non-Steroidal Anti-Inflammatory Drugs Indicated For: The Relief Of The Signs And Symptoms Of: Rheumatoid Arthritis Osteoarthritis Ankylosing Spondylitis Polyarticular Juvenile Idiopathic Arthritis

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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