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Last Updated: December 22, 2024

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, Sandoz Inc, 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, Mylan, Orbion Pharms, Strides Pharma, Sun Pharm Inds, Torrent, Zydus Pharms, Alkem Labs Ltd, Cadila Pharms Ltd, Hikma, Indoco, Ivax Pharms Inc, Jiangsu Hansoh Pharm, Natco Pharma, Qilu, Sunshine, Teva Pharms, Torrent Pharms Ltd, Endo Operations, and Epic Pharma Llc, and is included in forty-six 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 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	INJECTABLE;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	INJECTABLE;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:	INJECTABLE;INTRAMUSCULAR			Strength	10MG/VIAL
Approval Date:	Oct 24, 2011	TE:	AP	RLD:	No

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