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Last Updated: March 27, 2026

Details for New Drug Application (NDA): 202295

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NDA 202295 describes OLANZAPINE, which is a drug marketed by Am Regent, Aspiro, Eugia Pharma, Omnivium Pharms, 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-nine NDAs. It is available from forty-one 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 202295

Tradename:	OLANZAPINE
Applicant:	Alkem Labs Ltd
Ingredient:	olanzapine
Patents:	0

Pharmacology for NDA: 202295

Suppliers and Packaging for NDA: 202295

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Oct 20, 2015	TE:	AB	RLD:	No

Profile for product number 002

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

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	7.5MG
Approval Date:	Oct 20, 2015	TE:	AB	RLD:	No

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