Application Nr Approved Date Route Status External Links
ANDA076201 2002-11-06 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 Diclofenac Sodium Extended-Release Tablets, Usp And Other Treatment Options Before Deciding To Use Diclofenac Sodium Extended-Release Tablets. 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 (13 Total)

Name Structure Kind Function Status
1. Cetostearyl Alcohol CETOSTEARYL ALCOHOL Unresolved
2. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
3. Compressible Sugar COMPRESSIBLE SUGAR Molecular
4. Copovidone K25-31 COPOVIDONE K25-31 Unresolved
5. Acacia ACACIA Unresolved EMUL-Emulsifier , STAB-Stabilizer FS-Substances permitted as optional ingredient in a standardized food.
6. Hypromelloses HYPROMELLOSES Unresolved
7. Ferric Oxide Red FERRIC OXIDE RED Molecular
8. 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.
9. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
10. Povidones POVIDONES Unresolved
11. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.
12. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
13. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

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