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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 202862

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NDA 202862 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 202862

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

Pharmacology for NDA: 202862

Suppliers and Packaging for NDA: 202862

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OLANZAPINE	olanzapine	TABLET;ORAL	202862	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8243	0615-8243-39	30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8243-39)
OLANZAPINE	olanzapine	TABLET;ORAL	202862	ANDA	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8244	0615-8244-05	15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8244-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Aug 15, 2014	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Aug 15, 2014	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	7.5MG
Approval Date:	Aug 15, 2014	TE:	AB	RLD:	No

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