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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Chinese Patent Office
Daiichi Sankyo
US Department of Justice

Generated: May 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091265

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NDA 091265 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 091265
Applicant:Apotex Inc
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091265
Suppliers and Packaging for NDA: 091265
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OLANZAPINE olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 091265 ANDA Cardinal Health 55154-6672 E 55154-6672-0
OLANZAPINE olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 091265 ANDA Apotex Corp. 60505-3275 N 60505-3275-0

Profile for product number 001

Approval Date:Oct 24, 2011TE:ABRLD:No

Profile for product number 002

Approval Date:Oct 24, 2011TE:ABRLD:No

Profile for product number 003

Approval Date:Oct 24, 2011TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School
Chinese Patent Office
Federal Trade Commission
Argus Health

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