FDA Approved: DULOXETINE HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Limited)

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Summary

FDA approved Alembic Pharmaceuticals Limited's original ANDA for duloxetine hydrochloride, establishing a generic version of duloxetine.

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Diseases / indications

• Diabetic Peripheral Neuropathic Pain
• Fibromyalgia
• Generalized Anxiety Disorder
• Low Back Pain
• Major Depressive Disorder
• Musculoskeletal Pain
• Osteoarthritis

Drugs mentioned

• Duloxetine hydrochloride (duloxetine)

Snippet

ORIG AP for DULOXETINE HYDROCHLORIDE (DULOXETINE)