Application Nr Approved Date Route Status External Links
ANDA075910 2002-01-07 Oral DISCN 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 Diclofenac Sodium Extended-Release Tablets, Usp And Other Treatment Options Before Deciding To Use Diclofenac Sodium Extended-Release. Use The Lowest Effective Dose For The Shortest Duration Consistent With Individual Patient Treatment Goals (see Warnings). Diclofenac Sodium Extended-Release Tablets Are Indicated: ●for Relief Of The Signs And Symptoms Of Osteoarthritis ●for Relief Of The Signs And Symptoms Of Rheumatoid Arthritis

All Formulated Excipients (10 Total)

Name Structure Kind Function Status
1. Carnauba Wax CARNAUBA WAX Unresolved MISC-Miscellaneous GRAS-Generally recognized as safe.
2. Cetyl Alcohol CETYL ALCOHOL Molecular
3. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
4. Hypromelloses HYPROMELLOSES Unresolved
5. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
6. 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.
7. Povidones POVIDONES Unresolved
8. Ferric Oxide Yellow FERRIC OXIDE YELLOW Unresolved
9. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
10. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Diclofenac Sodium DICLOFENAC SODIUM ZINC1281