duloxetine 20 MG Delayed Release Oral Capsule
1 INDICATIONS AND USAGE Duloxetine delayed-release capsules are indicated for the treatment of: Major Depressive Disorder [see Clinical Studies ( 14.1 )] Generalized Anxiety Disorder [see Clinical Studies ( 14.2 )] Diabetic Peripheral Neuropathy [see Clinical Studies ( 14.3 )] Chronic Musculoskeletal Pain [see Clinical Studies ( 14.5 )] Duloxetine is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: Major Depressive Disorder (MDD) ( 1 ) Generalized Anxiety Disorder (GAD) ( 1 ) Diabetic Peripheral Neuropathic Pain (DPNP) ( 1 ) Chronic Musculoskeletal Pain ( 1 )
Zydus Pharmaceuticals (USA) Inc.
CAPSULE GREEN 385 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 "385" in golden ink and white body printed with "20 mg" in golden ink and are supplied as follows: NDC 70710-1537-3 in bottle of 30 capsules NDC 70710-1537-6 in bottle of 60 capsules NDC 70710-1537-9 in bottle of 90 capsules NDC 70710-1537-0 in bottle of 1000 capsules
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 "386" in golden ink and green-colored body printed with "30 mg" in golden ink and are supplied as follows: NDC 70710-1538-3 in bottle of 30 capsules NDC 70710-1538-9 in bottle of 90 capsules NDC 70710-1538-0 in bottle of 1000 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 "387" in golden ink and white-colored body printed with "60 mg" in golden ink and are supplied as follows: NDC 70710-1539-3 in bottle of 30 capsules NDC 70710-1539-9 in bottle of 90 capsules NDC 70710-1539-0 in bottle of 1000 capsules 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.
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