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Details for New Drug Application (NDA): 077742

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NDA 077742 describes OLANZAPINE AND FLUOXETINE HYDROCHLORIDE, which is a drug marketed by Sandoz, Teva Pharms, and Par Pharm, 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 NDA: 077742

Tradename:
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
Applicant:
Par Pharm
Ingredient:
fluoxetine hydrochloride; olanzapine
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 077742

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 077742

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride; olanzapine
CAPSULE;ORAL 077742 ANDA Par Pharmaceutical, Inc 49884-250 49884-250-01 100 CAPSULE in 1 BOTTLE, PLASTIC (49884-250-01)
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride; olanzapine
CAPSULE;ORAL 077742 ANDA Par Pharmaceutical, Inc 49884-250 49884-250-10 1000 CAPSULE in 1 BOTTLE, PLASTIC (49884-250-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG BASE;EQ 3MG BASE
Approval Date:Nov 2, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG BASE;EQ 6MG BASE
Approval Date:Nov 2, 2012TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 25MG BASE;EQ 12MG BASE
Approval Date:Nov 2, 2012TE:ABRLD:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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