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Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077243

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NDA 077243 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-seven 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 077243

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 077243

Suppliers and Packaging for NDA: 077243

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OLANZAPINE olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 077243 ANDA Teva Pharmaceuticals USA, Inc. 0093-5245 0093-5245-65 30 BLISTER PACK in 1 CARTON (0093-5245-65) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-5245-19)
OLANZAPINE olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 077243 ANDA Teva Pharmaceuticals USA, Inc. 0093-5246 0093-5246-65 30 BLISTER PACK in 1 CARTON (0093-5246-65) > 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0093-5246-19)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength5MG
Approval Date:Jan 30, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength10MG
Approval Date:Jan 30, 2012TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength15MG
Approval Date:Jan 30, 2012TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Deloitte
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Colorcon
Moodys
Cipla
Healthtrust
AstraZeneca
Chinese Patent Office
Argus Health
US Army

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