Application Nr Approved Date Route Status External Links
ANDA075219 1998-08-06 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 Potassium Tablets And Other Treatment Options Before Deciding To Use Diclofenac Potassium Tablets. Use The Lowest Effective Dose For The Shortest Duration Consistent With Individual Patient Treatment Goals (see Warnings; Gastrointestinal Bleeding, Ulceration, And Perforation). Diclofenac Potassium Tablets Are Indicated: •for Treatment Of Primary Dysmenorrhea •for Relief Of Mild To Moderate Pain •for Relief Of The Signs And Symptoms Of Osteoarthritis •for Relief Of The Signs And Symptoms Of Rheumatoid Arthritis

All Formulated Excipients (2 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. Starch, Corn STARCH, CORN Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Diclofenac Potassium DICLOFENAC POTASSIUM ZINC1281