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Last Updated: February 20, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203333


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NDA 203333 describes OLANZAPINE, which is a drug marketed by Am Regent, Sandoz Inc, Ajanta Pharma Ltd, Apotex Inc, Aurobindo Pharma Ltd, Barr Labs Inc, Dr Reddys Labs Ltd, Hec Pharm, Invagen Pharms, Jubilant Generics, Macleods Pharms Ltd, Mylan, Orchid Hlthcare, Par Pharm, Sun Pharm Inds, Torrent Pharms Llc, Alkem Labs Ltd, Hikma Pharms, Ivax Pharms Inc, Jiangsu Hansoh Pharm, Qilu, Sunshine Lake, Teva Pharms, Torrent Pharms Ltd, Zydus Pharms, and Sandoz, and is included in thirty-nine NDAs. It is available from thirty-five suppliers. Additional details are available on the OLANZAPINE profile page.

The generic ingredient in OLANZAPINE 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 203333
Tradename:OLANZAPINE
Applicant:Invagen Pharms
Ingredient:olanzapine
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Mar 15, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Mar 15, 2016TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG
Approval Date:Mar 15, 2016TE:ABRLD:No

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