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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Queensland Health
Argus Health

Generated: November 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090798

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NDA 090798 describes OLANZAPINE, which is a drug marketed by Teva Pharms, Ivax Pharms Inc, Aurobindo Pharma Ltd, Par Pharm, Ajanta Pharma Ltd, Torrent Pharms Llc, Qilu Pharm Co Ltd, Jubilant Generics, Dr Reddys Labs Ltd, Invagen Pharms, Torrent Pharms Ltd, Orchid Hlthcare, Sun Pharm Inds, Luitpold, Barr Labs Inc, Macleods Pharms Ltd, Apotex Inc, Hikma Pharms, Mylan Pharms Inc, Sandoz Inc, Alkem Labs 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 090798

Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 090798

Suppliers and Packaging for NDA: 090798

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 090798 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-954 43353-954-16 6000 TABLET, FILM COATED in 1 BOTTLE (43353-954-16)
TABLET;ORAL 090798 ANDA AvPAK 50268-609 50268-609-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-609-15) > 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-609-11)

Summary for product number 001

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

Summary for product number 002

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

Summary 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:

Cantor Fitzgerald
Chinese Patent Office
Express Scripts
Argus Health
Queensland Health

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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