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Last Updated: April 25, 2024

Details for New Drug Application (NDA): 021086

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NDA 021086 describes ZYPREXA ZYDIS, which is a drug marketed by Cheplapharm and is included in one NDA. It is available from two suppliers. Additional details are available on the ZYPREXA ZYDIS profile page.

The generic ingredient in ZYPREXA ZYDIS is olanzapine. There are thirty-three drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the olanzapine profile page.

Summary for 021086

Tradename:	ZYPREXA ZYDIS
Applicant:	Cheplapharm
Ingredient:	olanzapine
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021086

Suppliers and Packaging for NDA: 021086

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZYPREXA ZYDIS	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	021086	NDA	Eli Lilly and Company	0002-4453	0002-4453-85	30 DOSE PACK in 1 CARTON (0002-4453-85) / 1 BLISTER PACK in 1 DOSE PACK (0002-4453-01) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
ZYPREXA ZYDIS	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	021086	NDA	Eli Lilly and Company	0002-4454	0002-4454-85	30 DOSE PACK in 1 CARTON (0002-4454-85) / 1 BLISTER PACK in 1 DOSE PACK (0002-4454-01) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	5MG
Approval Date:	Apr 6, 2000	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	10MG
Approval Date:	Apr 6, 2000	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	15MG
Approval Date:	Apr 6, 2000	TE:	AB	RLD:	Yes

Expired US Patents for NDA 021086

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	ZYPREXA ZYDIS	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	021086-004	Apr 6, 2000	⤷ Try a Trial	⤷ Try a Trial
Cheplapharm	ZYPREXA ZYDIS	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	021086-003	Apr 6, 2000	⤷ Try a Trial	⤷ Try a Trial
Cheplapharm	ZYPREXA ZYDIS	olanzapine	TABLET, ORALLY DISINTEGRATING;ORAL	021086-003	Apr 6, 2000	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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