Last Updated: May 3, 2026

Details for New Drug Application (NDA): 220323

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NDA 220323 describes OLANZAPINE, which is a drug marketed by Am Regent, Anthea Pharma, 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 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 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 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 220323

Tradename:	OLANZAPINE
Applicant:	Anthea Pharma
Ingredient:	olanzapine
Patents:	0

Pharmacology for NDA: 220323

Suppliers and Packaging for NDA: 220323

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
OLANZAPINE	olanzapine	POWDER;INTRAMUSCULAR	220323	ANDA	GLENMARK PHARMACEUTICALS INC., USA	68462-952	68462-952-10	1 VIAL in 1 CARTON (68462-952-10) / 2 mL in 1 VIAL
OLANZAPINE	olanzapine	POWDER;INTRAMUSCULAR	220323	ANDA	Anthea Pharma Private Limited	83854-003	83854-003-01	1 VIAL in 1 CARTON (83854-003-01) / 2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;INTRAMUSCULAR			Strength	10MG/VIAL
Approval Date:	Mar 5, 2026	TE:	AP	RLD:	No

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