duloxetine 60 mg
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)
marksans pharma limited
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Duloxetine Delayed-Release capsules USP, 20 mg: Opaque green/opaque green size '4' hard gelatin capsule filled with white to off-white-spherical enteric coated pellets and imprinted 'RDY608' on opaque green cap and '20 mg' on opaque green body with black ink. Bottles of 60 NDC 25000-608-06 Duloxetine Delayed-Release capsules USP, 30 mg: Opaque blue/opaque white size '3' hard gelatin capsule filled with white to off-white-spherical enteric coated pellets and imprinted 'RDY609' on opaque blue cap and '30 mg' on opaque white body with golden yellow ink. Bottles of 30 NDC 25000-609-03 Bottles of 90 NDC 25000-609-07 Duloxetine Delayed-Release capsules USP, 60 mg: Opaque blue/opaque green size '1' hard gelatin capsule filled with white to off-white spherical enteric coated pellets and imprinted 'RDY610' on opaque blue cap and '60 mg' on opaque green body with white ink. Bottles of 30 NDC 25000-610-03 Bottles of 90 NDC 25000-610-07 16.2 Storage and Handling Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
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