Application Nr Approved Date Route Status External Links
ANDA075416 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Naproxen Sodium Extended-Release Tablets Are Indicated For The Treatment Of: Rheumatoid Arthritis (Ra) Osteoarthritis (Oa) Ankylosing Spondylitis (As) Tendinitis, Bursitis Acute Gout Primary Dysmenorrhea (Pd) The Relief Of Mild To Moderate Pain [See Warnings And Precautions (5) ] . Naproxen Sodium Extended-Release Tablets Are A Nonsteroidal Anti-Inflammatory Drug Indicated For The Treatment Of: Rheumatoid Arthritis (Ra)( 1 ) Osteoarthritis (Oa)( 1 ) Ankylosing Spondylitis (As)( 1 ) Tendinitis, Bursitis ( 1 ) Acute Gout ( 1 ) Primary Dysmenorrhea (Pd)( 1 ) The Relief Of Mild To Moderate Pain ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Naproxen Sodium NAPROXEN SODIUM ZINC105216

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