FDA Approved: PROZAC — Supplemental Application (Dista Products Company)

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Summary

FDA approved a supplemental application for Prozac (fluoxetine hydrochloride) submitted by Dista Products Company, approving changes to the product labeling.

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Diseases / indications

• Bulimia Nervosa
• Major Depressive Disorder
• Obsessive-compulsive Disorder
• Panic Disorder
• Premenstrual Dysphoric Disorder

Drugs mentioned

• Prozac (Fluoxetine)

Snippet

SUPPL AP for PROZAC (FLUOXETINE HYDROCHLORIDE)