duloxetine 30 MG Delayed Release Oral Capsule

1 INDICATIONS & 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 delayed-release capsule 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 )

camber pharmaceuticals, inc.

FDA Reported Adverse Reactions
`[1] drug ineffective` `[2] fatigue` `[3] nausea` `[4] pain` `[5] off label use` `[6] headache` `[7] dyspnoea` `[8] diarrhoea` `[9] arthralgia` `[10] vomiting`

4 years ago

CAPSULE BLUE H 191

16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Duloxetine Delayed-release capsules USP, 20 mg are Opaque green cap/Opaque green body size "4' hard gelatin capsule imprinted with "H" on cap and "190" on body, filled with off white colored pellets. They are supplied as follows: Bottles of 30 capsules (NDC 31722-581-30) Bottles of 60 capsules (NDC 31722-581-60) Bottles of 100 capsules (NDC 31722-581-01) Blister Card of 7 Unit-Dose capsules (31722-581-31) Blister Pack of 105 (15x7) Unit-Dose capsules (31722-581-32) Duloxetine Delayed-release capsules USP, 30 mg are Opaque blue cap/ Opaque white body size "3' hard gelatin capsule imprinted with 'H" on cap and "191" on body, filled with off white colored pellets. Bottles of 30 capsules (NDC 31722-582-30) Bottles of 90 capsules (NDC 31722-582-90) Bottles of 100 capsules (NDC 31722-582-01) Blister Card of 7 Unit-Dose capsules (31722-582-31) Blister Pack of 105 (15x7) Unit-Dose capsules (37122-582-32) Duloxetine Delayed-release capsules USP, 60 mg Opaque blue cap/ Opaque green body size "1" hard gelatin capsule imprinted with "H" on cap and '192" on body, filled with off white colored pellets. Bottles of 30 capsules (NDC 31722-583-30) Bottles of 100 capsules (NDC 31722-583-01) Blister Card of 10 Unit-Dose capsules (31722-583-31) Blister Pack of 90 (9x10) Unit-Dose capsules (31722-583-32) 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

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