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Serving 500+ biopharmaceutical companies globally:

Express Scripts
Argus Health
Fish and Richardson
US Army

Generated: June 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202295

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NDA 202295 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, Mylan Pharms Inc, Sandoz Inc, Alkem Labs Ltd, and Sandoz, and is included in thirty-four 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 NDA: 202295

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

Pharmacology for NDA: 202295

Suppliers and Packaging for NDA: 202295

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 202295 ANDA Ascend Laboratories, LLC 67877-172 67877-172-01 100 TABLET in 1 BOTTLE (67877-172-01)
TABLET;ORAL 202295 ANDA Ascend Laboratories, LLC 67877-172 67877-172-10 1000 TABLET in 1 BOTTLE (67877-172-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Oct 20, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Oct 20, 2015TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG
Approval Date:Oct 20, 2015TE:ABRLD:No

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Serving 500+ biopharmaceutical companies globally:

US Army
Cantor Fitzgerald
Johnson and Johnson
Federal Trade Commission
Farmers Insurance

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