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Last Updated: December 29, 2025

Details for New Drug Application (NDA): 218116

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NDA 218116 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 218116

Tradename:	OLANZAPINE
Applicant:	Qilu
Ingredient:	olanzapine
Patents:	0

Pharmacology for NDA: 218116

Suppliers and Packaging for NDA: 218116

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OLANZAPINE	olanzapine	INJECTABLE;INTRAMUSCULAR	218116	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9199	0143-9199-01	1 VIAL in 1 CARTON (0143-9199-01) / 2 mL in 1 VIAL
OLANZAPINE	olanzapine	INJECTABLE;INTRAMUSCULAR	218116	ANDA	Qilu Pharmaceutical Co., Ltd.	67184-0573	67184-0573-1	1 VIAL in 1 CARTON (67184-0573-1) / 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAMUSCULAR			Strength	10MG/VIAL
Approval Date:	May 16, 2025	TE:	AP	RLD:	No

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