duloxetine 20 MG Delayed Release Oral Capsule
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 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. 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)
Zydus Pharmaceuticals (USA) Inc.
CAPSULE GREEN 241 20mg
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
DULOXETINE Delayed-Release capsules, USP equivalent to 20 mg of
DULOXETINE are white to off-white free flowing pellets filled in size '4' hard gelatin capsules with green colored cap printed with "241" in golden ink and white body printed with "20 mg" in golden ink and are supplied as follows: NDC 68382-385-06 in bottle of 30 capsules with child-resistant closure NDC 68382-385-14 in bottle of 60 capsules with child-resistant closure NDC 68382-385-16 in bottle of 90 capsules with child-resistant closure
DULOXETINE Delayed-Release capsules, USP equivalent to 30 mg of
DULOXETINE are white to off-white free flowing pellets filled in size '3' hard gelatin capsules with blue-colored cap printed with "242" in golden ink and green-colored body printed with "30 mg" in golden ink and are supplied as follows: NDC 68382-386-06 in bottle of 30 capsules with child-resistant closure NDC 68382-386-16 in bottle of 90 capsules with child-resistant closure NDC 68382-386-10 in bottle of 1,000 capsules
DULOXETINE Delayed-Release capsules, USP equivalent to 60 mg of
DULOXETINE are white to off-white free flowing pellets filled in size '1' hard gelatin capsules with blue-colored cap printed with "243" in golden ink and white-colored body printed with "60 mg" in golden ink and are supplied as follows: NDC 68382-387-06 in bottle of 30 capsules with child-resistant closure NDC 68382-387-16 in bottle of 90 capsules with child-resistant closure NDC 68382-387-10 in bottle of 1,000 capsules 16.2 Storage and Handling Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.
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