FDA Approved: FLUOXETINE — Supplemental Application (Saptalis Pharmaceuticals, LLC.)

View source ↗

Summary

The FDA approved a supplemental application for fluoxetine from Saptalis Pharmaceuticals, LLC., enabling a generic fluoxetine product under an ANDA.

Upgrade for the full analysis, importance score, and drug timeline.

Diseases / indications

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

Drugs mentioned

• Fluoxetine (Fluoxetine)

Snippet

SUPPL AP for FLUOXETINE (FLUOXETINE)