duloxetine 40 MG Delayed Release Oral Capsule
1 INDICATIONS AND USAGE Duloxetine delayed-release capsule 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 )and pediatric patients 13 years of age and older ( 1 ) Chronic Musculoskeletal Pain in adults ( 1 ) 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
Lupin Pharmaceuticals, Inc.
CAPSULE WHITE LU H25
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
DULOXETINE is available as delayed-release capsules in the following strengths, colors, imprints, and presentations: Features Strengths 20 mg equivalent to
DULOXETINE base 30 mg 40 mg 60 mg Body color green white white green Cap color green Dark blue white Dark blue Cap imprint ‘LU’ ‘LU’ ‘LU’ ‘LU’ Body imprint ‘Q01’ ‘Q02’ ‘H25’ ‘Q03’ capsule number 4 3 2 1 Presentations and NDC Codes Bottles of 30 68180-294-06 68180-295-06 68180-297-06 68180-296-06 Bottles of 60 68180-294-07 Not Applicable Not Applicable Not Applicable Bottles of 90 68180-294-09 68180-295-09 68180-297-09 68180-296-09 Bottles of 1000 68180-294-03 68180-295-03 68180-297-03 68180-296-03 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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