Application Nr Approved Date Route Status External Links
ANDA201089 2012-07-09 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 And Misoprostol Delayed-Release Tablets And Other Treatment Options Before Deciding To Use Diclofenac Sodium And Misoprostol Delayed-Release Tablets. Use The Lowest Effective Dose For The Shortest Duration Consistent With Individual Patient Treatment Goals (see Warnings ). Diclofenac Sodium And Misoprostol Delayed-Release Tablets Are Indicated For Treatment Of The Signs And Symptoms Of Osteoarthritis Or Rheumatoid Arthritis In Patients At High Risk Of Developing Nsaid-Induced Gastric And Duodenal Ulcers And Their Complications. See Warnings , Gastrointestinal Effects - Risk Of Ulceration, Bleeding, And Perforation For A List Of Factors That May Increase The Risk Of Nsaid-Induced Gastric And Duodenal Ulcers And Their Complications.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

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