duloxetine
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 are 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 )