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Serving hundreds of leading biopharmaceutical companies globally:

US Army
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Farmers Insurance
Fish and Richardson
Boehringer Ingelheim

Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202074

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NDA 202074 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 202074
Applicant:Teva Pharms
Ingredient:fluoxetine hydrochloride; olanzapine
Formulation / Manufacturing:see details
Pharmacology for NDA: 202074
Mechanism of ActionSerotonin Uptake Inhibitors
Suppliers and Packaging for NDA: 202074
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride; olanzapine CAPSULE;ORAL 202074 ANDA Teva Pharmaceuticals USA, Inc. 0093-5503 N 0093-5503-56
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride; olanzapine CAPSULE;ORAL 202074 ANDA AvKARE, Inc. 42291-652 N 42291-652-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG BASE;EQ 3MG BASE
Approval Date:Mar 25, 2013TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Farmers Insurance
Chinese Patent Office

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