FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Alvogen, Inc.)

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Summary

FDA approved a supplemental application for sertraline hydrochloride (Alvogen), resulting in labeling changes to the approved NDA.

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Diseases / indications

• Major Depressive Disorder
• Obsessive-compulsive Disorder
• Panic Disorder
• Post-traumatic Stress Disorder
• Premenstrual Dysphoric Disorder
• Social Anxiety Disorder

Drugs mentioned

• Sertraline hydrochloride (sertraline hydrochloride)

Snippet

SUPPL AP for SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE)