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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 201588

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NDA 201588 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 201588

Tradename:	OLANZAPINE
Applicant:	Sandoz Inc
Ingredient:	olanzapine
Patents:	0

Pharmacology for NDA: 201588

Suppliers and Packaging for NDA: 201588

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OLANZAPINE	olanzapine	POWDER;INTRAMUSCULAR	201588	ANDA	Sandoz Inc	0781-3159	0781-3159-72	1 VIAL in 1 CARTON (0781-3159-72) / 2 mL in 1 VIAL
OLANZAPINE	olanzapine	POWDER;INTRAMUSCULAR	201588	ANDA	Sandoz Inc	0781-9105	0781-9105-72	1 VIAL in 1 CARTON (0781-9105-72) / 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAMUSCULAR			Strength	10MG/VIAL
Approval Date:	Oct 24, 2011	TE:	AP	RLD:	No

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