Duloxetine HCl

FDA Drug Profile

Drug Details

Generic Name
Duloxetine HCl
Brand Names
N/A
Application Number
Sponsor
Uquifa Spain
NDC Codes
2
Dosage Forms
POWDER
Routes
N/A
Active Ingredients
DULOXETINE HYDROCHLORIDE, DULOXETINE

Indications and Usage

Indications and Usage Duloxetine 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 Chronic musculoskeletal pain in adults Additional pediatric use information is approved for Eli Lilly and Company, Inc.’s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.