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Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077528

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NDA 077528 describes OLANZAPINE AND FLUOXETINE HYDROCHLORIDE, which is a drug marketed by Par Pharm, Sandoz, and Teva Pharms, and is included in four NDAs. It is available from four 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. Five suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride; olanzapine profile page.
Summary for 077528
Tradename:OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
Applicant:Teva Pharms
Ingredient:fluoxetine hydrochloride; olanzapine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077528
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 077528
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride; olanzapine CAPSULE;ORAL 077528 ANDA Teva Pharmaceuticals USA, Inc. 0093-5504 N 0093-5504-56
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride; olanzapine CAPSULE;ORAL 077528 ANDA Teva Pharmaceuticals USA, Inc. 0093-5505 N 0093-5505-56

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG BASE;EQ 6MG BASE
Approval Date:Jun 19, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG BASE;EQ 12MG BASE
Approval Date:Jun 19, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 50MG BASE;EQ 6MG BASE
Approval Date:Jun 19, 2012TE:ABRLD:No

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