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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 090459


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NDA 090459 describes OLANZAPINE, which is a drug marketed by Am Regent, Aspiro, Eugia Pharma, Sandoz Inc, Ajanta Pharma Ltd, Apotex Inc, Aurobindo Pharma Ltd, Barr Labs Inc, Chartwell Molecular, Dr Reddys Labs Ltd, Hec Pharm, Hisun Pharm Hangzhou, Jubilant Generics, Macleods Pharms Ltd, Mylan, Orbion Pharms, Strides Pharma, Sun Pharm Inds, Torrent, Zydus Pharms, Alkem Labs Ltd, Cadila Pharms Ltd, Hikma, Indoco, Ivax Pharms Inc, Jiangsu Hansoh Pharm, Qilu, Sunshine, Teva Pharms, Torrent Pharms Ltd, Epic Pharma Llc, and Par Pharm, and is included in forty-six NDAs. It is available from forty-three 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. Four suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride; olanzapine profile page.
Summary for 090459
Tradename:OLANZAPINE
Applicant:Zydus Pharms
Ingredient:olanzapine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 090459
Suppliers and Packaging for NDA: 090459
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OLANZAPINE olanzapine TABLET;ORAL 090459 ANDA Zydus Pharmaceuticals USA Inc. 68382-364 68382-364-01 100 TABLET, FILM COATED in 1 BOTTLE (68382-364-01)
OLANZAPINE olanzapine TABLET;ORAL 090459 ANDA Zydus Pharmaceuticals USA Inc. 68382-364 68382-364-06 30 TABLET, FILM COATED in 1 BOTTLE (68382-364-06)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Jul 16, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jul 16, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7.5MG
Approval Date:Jul 16, 2018TE:ABRLD:No

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