Application Nr Approved Date Route Status External Links
ANDA203088 2014-06-11 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)] •chronic Musculoskeletal Pain [see Clinical Studies (14.5)] Duloxetine Delayed-Release Capsules Are A Serotonin And Norepinephrine Reuptake Inhibitor (snri) Indicated For: 5.major Depressive Disorder (mdd) (1) 6.generalized Anxiety Disorder (gad) (1) 7.diabetic Peripheral Neuropathic Pain (dpnp) (1) 8.chronic Musculoskeletal Pain (1)

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
2. Hypromelloses HYPROMELLOSES Unresolved
3. Polysorbate 80 POLYSORBATE 80 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , MISC-Miscellaneous , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
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. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.
8. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
9. 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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