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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 076133

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NDA 076133 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 076133

Tradename:	OLANZAPINE
Applicant:	Dr Reddys Labs Ltd
Ingredient:	olanzapine
Patents:	0

Pharmacology for NDA: 076133

Suppliers and Packaging for NDA: 076133

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OLANZAPINE	olanzapine	TABLET;ORAL	076133	ANDA	Major Pharmaceuticals	0904-6286	0904-6286-61	100 BLISTER PACK in 1 CARTON (0904-6286-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
OLANZAPINE	olanzapine	TABLET;ORAL	076133	ANDA	Major Pharmaceuticals	0904-6287	0904-6287-61	100 BLISTER PACK in 1 CARTON (0904-6287-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	15MG
Approval Date:	Apr 23, 2012	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Oct 24, 2011	TE:	AB	RLD:	No

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