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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 206924

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NDA 206924 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 206924

Tradename:	OLANZAPINE
Applicant:	Hisun Pharm Hangzhou
Ingredient:	olanzapine
Patents:	0

Pharmacology for NDA: 206924

Suppliers and Packaging for NDA: 206924

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OLANZAPINE	olanzapine	TABLET;ORAL	206924	ANDA	Hisun Pharmaceuticals USA, Inc.	42658-150	42658-150-01	75 mg in 1 BOTTLE (42658-150-01)
OLANZAPINE	olanzapine	TABLET;ORAL	206924	ANDA	Hisun Pharmaceuticals USA, Inc.	42658-150	42658-150-04	225 mg in 1 BOTTLE (42658-150-04)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Dec 31, 2020	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Dec 31, 2020	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	7.5MG
Approval Date:	Dec 31, 2020	TE:		RLD:	No

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