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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 211072

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NDA 211072 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. Four suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride; olanzapine profile page.

Summary for 211072

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

Pharmacology for NDA: 211072

Suppliers and Packaging for NDA: 211072

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OLANZAPINE	olanzapine	INJECTABLE;INTRAMUSCULAR	211072	ANDA	PAI Holdings, LLC dba PAI Pharma	0121-1072	0121-1072-55	1 VIAL in 1 CARTON (0121-1072-55) / 2 mL in 1 VIAL
OLANZAPINE	olanzapine	INJECTABLE;INTRAMUSCULAR	211072	ANDA	XGen Pharmaceuticals DJB, Inc.	39822-1800	39822-1800-1	1 VIAL in 1 CARTON (39822-1800-1) / 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAMUSCULAR			Strength	10MG/VIAL
Approval Date:	Jun 11, 2025	TE:	AP	RLD:	No

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