Application Nr Approved Date Route Status External Links
ANDA074514 1996-03-26 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. Use The Lowest Effective Dose For The Shortest Duration Consistent With Individual Patient Treatment Goals (see Warnings). Diclofenac Sodium Delayed-Release Tablets Are 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 (12 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Hypromelloses HYPROMELLOSES Unresolved
3. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
4. 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.
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
6. Polyethylene Glycols POLYETHYLENE GLYCOLS Unresolved
7. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
8. Polyvinyl Acetate Phthalate POLYVINYL ACETATE PHTHALATE Unresolved
9. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
10. Sodium Alginate SODIUM ALGINATE Unresolved BC-Boiler compound , STAB-Stabilizer REG-Food additives for which a petition has been filed and a regulation issued.
11. Stearic Acid STEARIC ACID Molecular MISC-Miscellaneous GRAS-Generally recognized as safe.
12. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

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