Last Updated: September 24, 2026

Details for New Drug Application (NDA): 020592

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NDA 020592 describes ZYPREXA, which is a drug marketed by Cheplapharm and is included in four NDAs. It is available from one supplier. Additional details are available on the ZYPREXA profile page.

The generic ingredient in ZYPREXA is olanzapine pamoate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the olanzapine pamoate profile page.

Summary for 020592

Tradename:	ZYPREXA
Applicant:	Cheplapharm
Ingredient:	olanzapine
Patents:	0

Pharmacology for NDA: 020592

Suppliers and Packaging for NDA: 020592

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZYPREXA	olanzapine	TABLET;ORAL	020592	NDA	H2-Pharma LLC	61269-630	61269-630-30	30 TABLET in 1 BOTTLE (61269-630-30)
ZYPREXA	olanzapine	TABLET;ORAL	020592	NDA	H2-Pharma LLC	61269-631	61269-631-30	30 TABLET in 1 BOTTLE (61269-631-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	2.5MG
Approval Date:	Sep 30, 1996	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Sep 30, 1996	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	7.5MG
Approval Date:	Sep 30, 1996	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020592

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-001	Sep 30, 1996	⤷ Start Trial	⤷ Start Trial
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-004	Sep 30, 1996	⤷ Start Trial	⤷ Start Trial
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-003	Sep 30, 1996	⤷ Start Trial	⤷ Start Trial
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-005	Sep 9, 1997	⤷ Start Trial	⤷ Start Trial
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-002	Sep 30, 1996	⤷ Start Trial	⤷ Start Trial
Cheplapharm	ZYPREXA	olanzapine	TABLET;ORAL	020592-006	Sep 9, 1997	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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