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duloxetine 60 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 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 )

apotex corp.


4 years ago CAPSULE GREEN APO D60 duloxetine 60 MG Delayed Release Oral Capsule

CAPSULE GREEN APO D60

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Duloxetine Delayed-release capsules, USP are supplied as: 20 mg capsules: Hard gelatin capsule with a green opaque body and green opaque cap. Imprinted “APO D20” in black ink. Filled with white to off-white granules. Bottles of 60 (NDC 60505-2995-6) 30 mg capsules : Hard gelatin capsule with a white opaque body and blue opaque cap. Imprinted “APO D30” in green ink. Filled with white to off-white granules. Bottles of 30 (NDC 60505-2996-3) 60 mg capsules : Hard gelatin capsules with a green opaque body and blue opaque cap. Imprinted “APO D60” in white ink. Filled with white to off-white granules. Bottles of 30 (NDC 60505-2997-3) 16.2 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].


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