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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 078901


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NDA 078901 describes OLANZAPINE AND FLUOXETINE HYDROCHLORIDE, which is a drug marketed by Endo Operations, Epic Pharma Llc, and Teva Pharms, and is included in four NDAs. It is available from three suppliers. Additional details are available on the OLANZAPINE AND FLUOXETINE HYDROCHLORIDE profile page.

The generic ingredient in OLANZAPINE AND FLUOXETINE HYDROCHLORIDE is fluoxetine hydrochloride; olanzapine. There are twenty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride; olanzapine profile page.
Summary for 078901

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG BASE;EQ 6MG BASE
Approval Date:Nov 16, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE;EQ 6MG BASE
Approval Date:Nov 16, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG BASE;EQ 12MG BASE
Approval Date:Nov 16, 2012TE:ABRLD:No

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