duloxetine

FDA Drug Profile — duloxetine

duloxetine is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand name including duloxetine. Available dosage form: capsule, delayed release.

Drug Details

Generic Name
duloxetine
Brand Names
duloxetine
Application Number
ANDA202336
Sponsor
Inventia Healthcare Limited.
NDC Codes
3
Dosage Forms
CAPSULE, DELAYED RELEASE
Routes
ORAL
Active Ingredients
DULOXETINE HYDROCHLORIDE

Indications and Usage

1 INDICATIONS AND USAGE Duloxetine delayed-release capsules is indicated for the treatment of: Major depressive disorder in adults Generalized anxiety disorder in adults and pediatric patients 7 years of age and older Diabetic peripheral neuropathic pain in adults Fibromyalgia in adults and pediatric patients 13 years of age and older Chronic musculoskeletal pain in adults Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: Major depressive disorder (MDD) in adults ( 1 ) Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older ( 1 ) Diabetic peripheral neuropathic pain (DPNP) in adults ( 1 ) Fibromyalgia (FM) in adults and pediatric patients 13 years of age and older ( 1 ) Chronic musculoskeletal pain in adults ( 1 )