.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077528

« Back to Dashboard
NDA 077528 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: 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 0093-5504-56 30 CAPSULE in 1 BOTTLE (0093-5504-56)
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
fluoxetine hydrochloride; olanzapine
CAPSULE;ORAL 077528 ANDA Teva Pharmaceuticals USA, Inc. 0093-5505 0093-5505-56 30 CAPSULE in 1 BOTTLE (0093-5505-56)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

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.

`abc