FDA Approved: OLANZAPINE AND FLUOXETINE — Supplemental Application (Par Health USA, LLC)

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Summary

FDA announces a supplemental approval for a generic fixed-dose combination of olanzapine and fluoxetine by Par Health USA, LLC under ANDA 077742.

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Diseases / indications

• Bipolar Disorder
• Major Depressive Disorder
• Treatment-resistant Depression

Drugs mentioned

• Olanzapine and fluoxetine (olanzapine; fluoxetine)

Snippet

SUPPL AP for OLANZAPINE AND FLUOXETINE (OLANZAPINE AND FUOXETINE)