Application Nr Approved Date Route Status External Links
ANDA202964 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Diclofenac Potassium For Oral Solution Is Indicated For The Acute Treatment Of Migraine Attacks With Or Without Aura In Adults (18 Years Of Age Or Older). Limitations Of Use: Diclofenac Potassium For Oral Solution Is Not Indicated For The Prophylactic Therapy Of Migraine. The Safety And Effectiveness Of Diclofenac Potassium For Oral Solution Have Not Been Established For Cluster Headache, Which Is Present In An Older, Predominantly Male Population. Diclofenac Potassium For Oral Solution Is A Non-Steroidal Anti-Inflammatory Drug (Nsaid) Indicated For The Acute Treatment Of Migraine Attacks With Or Without Aura In Adults 18 Years Of Age Or Older ( 1 ) Limitations Of Use ( 1 ): Diclofenac Potassium For Oral Solution Is Not Indicated For The Prophylactic Therapy Of Migraine Safety And Effectiveness Of Diclofenac Potassium For Oral Solution Not Established For Cluster Headache, Which Is Present In An Older, Predominantly Male Population

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

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

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