1 INDICATIONS AND USAGE Duloxetine delayed-release capsules USP are indicated for the treatment of: â€¢ Major Depressive disorder in adults â€¢ Generalized Anxiety disorder in adults and pediatric patients 7 years of age and older â€¢ Diabetic peripheral neuropathic pain in adults â€¢ Fibromyalgia in adults â€¢ Chronic Musculoskeletal Pain in adults Additional pediatric use information is approved for Eli Lilly and Company, Inc.â€™s CYMBALTA (duloxetine) delayed-release capsules. However, due to Eli Lilly and Company Inc.â€™s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Duloxetine is 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 ( 1 ) Chronic Musculoskeletal Pain in adults ( 1 )
Sun Pharmaceutical Industries, Inc.
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
DULOXETINE delayed-release capsules USP are available in the following strengths, colors, imprints, and presentations: Features Strengths 20 mg 30 mg 60 mg Body color green white green Cap color green blue blue Cap imprint 381 382 383 Body imprint 381 382 383 capsule Size 4 3 1 Presentations and NDC Codes Bottles of 30 with child-resistant closure 47335-381-83 47335-382-83 47335-383-83 Bottles of 60 with child-resistant closure 47335-381-86 - - Bottles of 90 with child-resistant closure - 47335-382-81 - Bottles of 100 with child-resistant closure 47335-381-88 47335-382-88 47335-383-88 Bottles of 100 47335-381-08 47335-382-08 47335-383-08 Bottles of 1000 47335-381-18 47335-382-18 47335-383-18 Unit dose blisters of 100 47335-381-61 47335-382-61 47335-383-61 16.2 Storage and Handling Store
DULOXETINE delayed-release capsules USP at 20Â° to 25Â°C (68Â° to 77Â°F); excursions permitted between 15Â° and 30Â°C (59Â° and 86Â°F) [see USP Controlled Room Temperature]. Dispense in a tightly closed container.
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