Application Nr Approved Date Route Status External Links
ANDA201089 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage 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. For A List Of Factors That May Increase The Risk Of Nsaid-Induced Gastric And Duodenal Ulcers And Their Complications [see Warnings And Precautions (5.2) ]. Diclofenac Sodium And Misoprostol Delayed-Release Tablets Are A Combination Non-Steroidal Anti-Inflammatory And Prostaglandin E 1 Analog Drug Indicated For The Treatment Of Signs And Symptoms Of Osteoarthritis (oa) Or Rheumatoid Arthritis (ra) In Patients At High Risk Of Developing Nsaid-Induced Gastric And Duodenal Ulcers And Their Complications ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

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