Application Nr Approved Date Route Status External Links
ANDA090739 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Duloxetine Delayed-Release Capsules Are Indicated For The Treatment Of: Major Depressive Disorder In Adults Generalized Anxiety Disorder In Adults And Pediatric Patients 7 Years Of Age And Older Diabetic Peripheral Neuropathic Pain In Adults Fibromyalgia In Adults Chronic Musculoskeletal Pain In Adults Pediatric Use Information For Fibromyalgia Is Approved For Eli Lilly And Company's Cymbalta ® (Duloxetine) Delayed-Release Capsules. However, Due To Eli Lilly And Company's Marketing Exclusivity Rights, This Drug Product Is Not Labeled With That Pediatric Information. Duloxetine Is A Serotonin And Norepinephrine Reuptake Inhibitor (Snri) Indicated For The Treatment Of The Following Conditions: Major Depressive Disorder (Mdd) In Adults (1) Generalized Anxiety Disorder (Gad) In Adults And Pediatric Patients 7 Years Of Age And Older (1) Diabetic Peripheral Neuropathic Pain (Dpnp) In Adults (1) Fibromyalgia (Fm) In Adults (1) Chronic Musculoskeletal Pain In Adults (1)

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Duloxetine Hydrochloride DULOXETINE HYDROCHLORIDE ZINC1536779

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