Application Nr Approved Date Route Status External Links
ANDA090783 2013-12-11 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: •major Depressive Disorder (mdd) (1) •generalized Anxiety Disorder (gad) (1) •diabetic Peripheral Neuropathic Pain (dpnp) (1) •chronic Musculoskeletal Pain (1)

All Formulated Excipients (12 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Gelatin GELATIN Unresolved
3. Hypromelloses HYPROMELLOSES Unresolved
4. Hypromellose Phthalate HYPROMELLOSE PHTHALATE Unresolved
5. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
6. Povidones POVIDONES Unresolved
7. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
8. Shellac SHELLAC Unresolved
9. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
10. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.
11. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
12. 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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