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Last Updated: November 11, 2019

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Details for New Drug Application (NDA): 021086

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NDA 021086 describes ZYPREXA ZYDIS, which is a drug marketed by Lilly and is included in one NDA. It is available from one supplier. 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. Thirty-seven suppliers are listed for this compound. Additional details are available on the olanzapine profile page.
Summary for 021086
Tradename:ZYPREXA ZYDIS
Applicant:Lilly
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
Paragraph IV (Patent) Challenges for 021086
Tradename Dosage Ingredient NDA Submissiondate
ZYPREXA ZYDIS TABLET, ORALLY DISINTEGRATING;ORAL olanzapine 021086

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength5MG
Approval Date:Apr 6, 2000TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength10MG
Approval Date:Apr 6, 2000TE:ABRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength15MG
Approval Date:Apr 6, 2000TE:ABRLD:Yes

Expired US Patents for NDA 021086

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly ZYPREXA ZYDIS olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086-001 Apr 6, 2000   Start Trial   Start Trial
Lilly ZYPREXA ZYDIS olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086-004 Apr 6, 2000   Start Trial   Start Trial
Lilly ZYPREXA ZYDIS olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086-003 Apr 6, 2000   Start Trial   Start Trial
Lilly ZYPREXA ZYDIS olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086-003 Apr 6, 2000   Start Trial   Start Trial
Lilly ZYPREXA ZYDIS olanzapine TABLET, ORALLY DISINTEGRATING;ORAL 021086-004 Apr 6, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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