FDA Approved: PAROXETINE HYDROCHLORIDE — Supplemental Application (Apotex Corp)

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Summary

FDA supplemental approval granted for Apotex Corp's paroxetine hydrochloride product, approving a generic formulation under NDA 020936.

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Diseases / indications

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

Drugs mentioned

• PAROXETINE HYDROCHLORIDE (Paroxetine hydrochloride)

Snippet

SUPPL AP for PAROXETINE HYDROCHLORIDE (PAROXETINE HYDROCHLORIDE)