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Last Updated: May 15, 2021

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Details for New Drug Application (NDA): 202287

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NDA 202287 describes OLANZAPINE, which is a drug marketed by Am Regent, Aurobindo Pharma Ltd, Sandoz Inc, Ajanta Pharma Ltd, Apotex Inc, Barr Labs Inc, Dr Reddys Labs Ltd, Hec Pharm, Hisun Pharm Hangzhou, Invagen Pharms, Jubilant Generics, Macleods Pharms Ltd, Mylan, Orchid Hlthcare, Par Pharm, Sun Pharm Inds, Torrent Pharms Llc, Alkem Labs Ltd, Hikma, Indoco, Ivax Pharms Inc, Jiangsu Hansoh Pharm, Qilu, Sunshine, Teva Pharms, Torrent Pharms Ltd, Zydus Pharms, and Sandoz, and is included in forty-three NDAs. It is available from thirty-six 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. Four suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride; olanzapine profile page.
Summary for 202287
Tradename:OLANZAPINE
Applicant:Orchid Hlthcare
Ingredient:olanzapine
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Apr 23, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Apr 23, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG
Approval Date:Apr 23, 2012TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

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