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Generated: February 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091038

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NDA 091038 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 091038
Tradename:OLANZAPINE
Applicant:Sun Pharm Inds
Ingredient:olanzapine
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091038
Suppliers and Packaging for NDA: 091038
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OLANZAPINE olanzapine TABLET;ORAL 091038 ANDA REMEDYREPACK INC. 52125-222 N 52125-222-02
OLANZAPINE olanzapine TABLET;ORAL 091038 ANDA REMEDYREPACK INC. 61786-443 N 61786-443-02

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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