Last Updated: November 13, 2026

Details for New Drug Application (NDA): 203708

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NDA 203708 describes OLANZAPINE, which is a drug marketed by Adaptis, 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, 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, Macleods Pharms Ltd, Natco Pharma, Sunshine, Teva Pharms, Torrent Pharms Ltd, Epic Pharma Llc, and Ph Health, and is included in fifty 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 two 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 203708

Tradename:	OLANZAPINE
Applicant:	Aurobindo Pharma Ltd
Ingredient:	olanzapine
Patents:	0

Pharmacology for NDA: 203708

Suppliers and Packaging for NDA: 203708

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OLANZAPINE	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	203708	ANDA	Aurobindo Pharma Limited	65862-656	65862-656-03	3 BLISTER PACK in 1 CARTON (65862-656-03) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65862-656-10)
OLANZAPINE	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	203708	ANDA	Aurobindo Pharma Limited	65862-657	65862-657-03	3 BLISTER PACK in 1 CARTON (65862-657-03) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (65862-657-10)

Profile for product number 001

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

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	10MG
Approval Date:	May 15, 2014	TE:	AB	RLD:	No

Profile for product number 003

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

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