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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 203044

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NDA 203044 describes OLANZAPINE, which is a drug marketed by Am Regent, Aspiro, Eugia Pharma, Qilu, Sandoz Inc, UBI, 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, Orbion Pharms, Pharmobedient, Strides Pharma Intl, Sun Pharm Inds, Torrent, Zydus Pharms, Alkem Labs Ltd, Cadila Pharms Ltd, Hikma, Indoco, Ivax Pharms Inc, Jiangsu Hansoh Pharm, Natco Pharma, Sunshine, Teva Pharms, Torrent Pharms Ltd, Epic Pharma Llc, and Ph Health, and is included in forty-eight 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. Three suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride; olanzapine profile page.

Summary for 203044

Tradename:	OLANZAPINE
Applicant:	Macleods Pharms Ltd
Ingredient:	olanzapine
Patents:	0

Pharmacology for NDA: 203044

Suppliers and Packaging for NDA: 203044

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OLANZAPINE	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	203044	ANDA	Macleods Pharmaceuticals Limited	33342-083	33342-083-07	30 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-083-07)
OLANZAPINE	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	203044	ANDA	Macleods Pharmaceuticals Limited	33342-083	33342-083-11	100 TABLET, ORALLY DISINTEGRATING in 1 CONTAINER (33342-083-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	5MG
Approval Date:	Feb 20, 2015	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	10MG
Approval Date:	Feb 20, 2015	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	15MG
Approval Date:	Feb 20, 2015	TE:	AB	RLD:	No

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