Irenka

Product manufactured by Lupin Pharma

Application Nr Approved Date Route Status External Links
ANDA090694 2013-12-11 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Irenka™ Is 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) Irenka™ Is 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]

All Formulated Excipients (12 Total)

Name Structure Kind Function Status
1. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
2. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
3. Gelatin GELATIN Unresolved
4. Hypromelloses HYPROMELLOSES Unresolved
5. Hypromellose Phthalate HYPROMELLOSE PHTHALATE Unresolved
6. Lactose Monohydrate LACTOSE MONOHYDRATE Molecular
7. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
8. 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.
9. Potassium Hydroxide POTASSIUM HYDROXIDE Molecular B&N-Buffer & neutralizing agent , MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
10. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
11. Shellac SHELLAC Unresolved
12. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

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