Application Nr Approved Date Route Status External Links
ANDA090723 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 Serotonin And Norepinephrine Reuptake Inhibitor (snri) Indicated For: • Major Depressive Disorder (mdd) (1.1) • Generalized Anxiety Disorder (gad) (1.2) • Diabetic Peripheral Neuropathic Pain (dpnp) (1.3) • Chronic Musculoskeletal Pain (1.5) 1.1 Major Depressive Disorder Duloxetine Delayed-Release Capsules Are Indicated For The Treatment Of Major Depressive Disorder (mdd). The Efficacy Of Duloxetine Was Established In Four Short Term And One Maintenance Trial In Adults [see Clinical Studies (14.1) ]. A Major Depressive Episode (dsm-Iv) Implies A Prominent And Relatively Persistent (nearly Every Day For At Least 2 Weeks) Depressed Or Dysphoric Mood That Usually Interferes With Daily Functioning, And Includes At Least 5 Of The Following 9 Symptoms: Depressed Mood, Loss Of Interest In Usual Activities, Significant Change In Weight And/or Appetite, Insomnia Or Hypersomnia, Psychomotor Agitation Or Retardation, Increased Fatigue, Feelings Of Guilt Or Worthlessness, Slowed Thinking Or Impaired Concentration, Or A Suicide Attempt Or Suicidal Ideation. 1.2 Generalized Anxiety Disorder Duloxetine Delayed-Release Capsules Are Indicated For The Treatment Of Generalized Anxiety Disorder (gad). The Efficacy Of Duloxetine Was Established In Three Short-Term Trials And One Maintenance Trial In Adults [see ]. Duloxetine Delayed-Release Capsules Are Indicated For The Treatment Of Generalized Anxiety Disorder (gad). The Efficacy Of Duloxetine Was Established In Three Short-Term Trials And One Maintenance Trial In Adults [see Clinical Studies (14.2) ]. Generalized Anxiety Disorder Is Defined By The Dsm-Iv As Excessive Anxiety And Worry, Present More Days Than Not, For At Least 6 Months. The Excessive Anxiety And Worry Must Be Difficult To Control And Must Cause Significant Distress Or Impairment In Normal Functioning. It Must Be Associated With At Least 3 Of The Following 6 Symptoms: Restlessness Or Feeling Keyed Up Or On Edge, Being Easily Fatigued, Difficulty Concentrating Or Mind Going Blank, Irritability, Muscle Tension, And/or Sleep Disturbance.generalized Anxiety Disorder Is Defined By The Dsm-Iv As Excessive Anxiety And Worry, Present More Days Than Not, For At Least 6 Months. The Excessive Anxiety And Worry Must Be Difficult To Control And Must Cause Significant Distress Or Impairment In Normal Functioning. It Must Be Associated With At Least 3 Of The Following 6 Symptoms: Restlessness Or Feeling Keyed Up Or On Edge, Being Easily Fatigued, Difficulty Concentrating Or Mind Going Blank, Irritability, Muscle Tension, And/or Sleep Disturbance. 1.3 Diabetic Peripheral Neuropathic Pain Duloxetine Delayed-Release Capsules Are Indicated For The Management Of Neuropathic Pain (dpnp) Associated With Diabetic Peripheral Neuropathy [see Clinical Studies (14.3) ]. 1.5 Chronic Musculoskeletal Pain Duloxetine Delayed-Release Capsules Are Indicated For The Management Of Chronic Musculoskeletal Pain. This Has Been Established In Studies In Patients With Chronic Low Back Pain (clbp) And Chronic Pain Due To Osteoarthritis [see Clinical Studies ( 14.5) ].

All Formulated Excipients (11 Total)

Name Structure Kind Function Status
1. Gelatin GELATIN Unresolved
2. Glycine GLYCINE Molecular MISC-Miscellaneous , NUTR-Nutrient , STAB-Stabilizer REG-Food additives for which a petition has been filed and a regulation issued.
3. Hypromellose Phthalate HYPROMELLOSE PHTHALATE Unresolved
4. Hypromelloses HYPROMELLOSES Unresolved
5. Ferric Oxide Yellow FERRIC OXIDE YELLOW Molecular
6. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
7. Shellac SHELLAC Unresolved
8. 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.
9. Sucrose SUCROSE Molecular NUTRS-Nutritive Sweetener GRAS-Generally recognized as safe.
10. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
11. 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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