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US Department of Justice
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Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202285

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NDA 202285 describes OLANZAPINE, which is a drug marketed by Luitpold, Sandoz Inc, Ajanta Pharma Ltd, Apotex Inc, Aurobindo Pharma Ltd, Barr Labs Inc, Dr Reddys Labs Ltd, Invagen Pharms, Jubilant Generics, Macleods Pharms Ltd, Mylan Pharms Inc, Orchid Hlthcare, Par Pharm, Sun Pharm Inds, Torrent Pharms Llc, Alkem Labs Ltd, Hikma Pharms, Ivax Pharms Inc, Qilu Pharm Co Ltd, Teva Pharms, Torrent Pharms Ltd, and Sandoz, and is included in thirty-five NDAs. It is available from thirty-eight 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 202285
Tradename:OLANZAPINE
Applicant:Mylan Pharms Inc
Ingredient:olanzapine
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 202285
Suppliers and Packaging for NDA: 202285
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OLANZAPINE olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 202285 ANDA Mylan Pharmaceuticals Inc. 0378-5510 N 0378-5510-93
OLANZAPINE olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 202285 ANDA Mylan Pharmaceuticals Inc. 0378-5511 N 0378-5511-93

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength5MG
Approval Date:May 12, 2014TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength10MG
Approval Date:May 12, 2014TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength15MG
Approval Date:May 12, 2014TE:ABRLD:No

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