Duloxetine

Product manufactured by Actavis Pharma, Inc.

Application Nr Approved Date Route Status External Links
ANDA090776 2013-12-17 Oral RX 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 [see Clinical Studies (14.1)] Generalized Anxiety Disorder [see Clinical Studies (14.2)] Diabetic Peripheral Neuropathy [see Clinical Studies (14.3)] Fibromyalgia [see Clinical Studies (14.4)] Chronic Musculoskeletal Pain [see Clinical Studies (14.5)] Duloxetine Delayed-Release Capsules Are A Serotonin And Norepinephrine Reuptake Inhibitor (snri) Indicated For: Major Depressive Disorder (mdd) (1) Generalized Anxiety Disorder (gad) (1) Diabetic Peripheral Neuropathic Pain (dpnp) (1) Fibromyalgia (fm) (1) Chronic Musculoskeletal Pain (1)

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
2. Gelatin GELATIN Unresolved
3. Hypromelloses HYPROMELLOSES Unresolved
4. Potassium Hydroxide POTASSIUM HYDROXIDE Molecular B&N-Buffer & neutralizing agent , MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
5. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
6. Shellac SHELLAC Unresolved
7. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
8. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

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

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