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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 217466

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NDA 217466 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 217466

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

Pharmacology for NDA: 217466

Suppliers and Packaging for NDA: 217466

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OLANZAPINE	olanzapine	INJECTABLE;INTRAMUSCULAR	217466	ANDA	Camber Pharmaceuticals, Inc.	31722-308	31722-308-01	1 VIAL in 1 CARTON (31722-308-01) / 2 mL in 1 VIAL
OLANZAPINE	olanzapine	INJECTABLE;INTRAMUSCULAR	217466	ANDA	NorthStar RxLLC	72603-181	72603-181-01	1 VIAL in 1 CARTON (72603-181-01) / 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAMUSCULAR			Strength	10MG/VIAL
Approval Date:	Mar 22, 2023	TE:	AP	RLD:	No

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