Application Nr Approved Date Route Status External Links
ANDA075185 1998-11-13 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. Use The Lowest Effective Dose For The Shortest Duration Consistent With Individual Patient Treatment Goals ( See Warnings; Gastrointestinal Bleeding, Ulceration, And Perforation ). Diclofenac Is Indicated: For Relief Of The Signs And Symptoms Of Osteoarthritis For Relief Of The 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 (10 Total)

Name Structure Kind Function Status
1. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
2. 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.
3. Methacrylic Acid Copolymer METHACRYLIC ACID COPOLYMER Unresolved
4. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
5. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
6. Povidones POVIDONES Unresolved
7. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
8. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
9. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
10. Triethyl Citrate TRIETHYL CITRATE Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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