Application Nr Approved Date Route Status External Links
ANDA077863 2007-06-08 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 Delayed-Release Tablets And Other Treatment Options Before Deciding To Use Diclofenac Sodium Delayed-Release Tablets. Use The Lowest Effective Dose For The Shortest Duration Consistent With Individual Patient Treatment Goals (see Warnings). Diclofenac Sodium Delayed-Release Tablets, Usp, Are Indicated: For Relief Of Signs And Symptoms Of Osteoarthritis For Relief Of Signs And Symptoms Of Rheumatoid Arthritis For Acute Or Long-Term Use In The Relief Of Signs And Symptoms Of Ankylosing Spondylitis

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
2. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
3. Povidones POVIDONES Unresolved
4. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
5. 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.
6. Methacrylic Acid Copolymer METHACRYLIC ACID COPOLYMER Unresolved
7. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
8. Hypromelloses HYPROMELLOSES Unresolved
9. Ferric Oxide Red FERRIC OXIDE RED Molecular

Active Ingredients ( 1 Total)

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

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