← FDA DRUG APPROVALS

FDA NDA · NDA021086

ZYPREXA ZYDIS

olanzapine

Sponsor: CHEPLAPHARM

APPLICATION
NDA021086
TYPE
NDA
ORIGINAL APPROVAL
2000-04-06
LATEST ACTION
2026-01-30
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription

Products

ZYPREXA ZYDIS · ReferencePrescription
OLANZAPINE 20MG · TABLET, ORALLY DISINTEGRATING · ORAL
ZYPREXA ZYDIS · ReferencePrescription
OLANZAPINE 10MG · TABLET, ORALLY DISINTEGRATING · ORAL
ZYPREXA ZYDIS · ReferencePrescription
OLANZAPINE 15MG · TABLET, ORALLY DISINTEGRATING · ORAL
ZYPREXA ZYDIS · ReferencePrescription
OLANZAPINE 5MG · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2026-01-30Labeling · Supplement 53 · standardLetterAP
2025-01-22Labeling · Supplement 50 · standardLabelAP
2020-04-23Labeling · Supplement 48 · standardLabelAP
2020-04-21Labeling · Supplement 49 · 901 requiredLetterAP
2019-10-22Labeling · Supplement 47 · standardLetterAP
2018-03-27Labeling · Supplement 46 · standardLabelAP
2017-02-23Labeling · Supplement 45 · 901 requiredLabelAP
2017-02-23Labeling · Supplement 44 · standardLabelAP
2016-10-06Labeling · Supplement 43 · 901 requiredLetterAP
2015-07-23Labeling · Supplement 42 · standardLabelAP
2014-12-19Labeling · Supplement 40 · standardLetterAP
2013-07-26Efficacy · Supplement 41 · standardLetterAP
2011-06-21REMS · Supplement 39LetterAP
2011-06-21REMS · Supplement 38LetterAP
2010-12-01Labeling · Supplement 36 · 901 requiredLetterAP
2010-05-27Labeling · Supplement 32 · unknownLabelAP
2010-05-27Labeling · Supplement 34 · unknownLetterAP
2010-01-27Labeling · Supplement 31 · unknownLetterAP
2009-08-31Labeling · Supplement 30 · unknownLetterAP
2009-03-19Efficacy · Supplement 21 · priorityLabelAP
2008-08-14Labeling · Supplement 28 · standardLetterAP
2007-07-06Labeling · Supplement 22 · standardLetterAP
2007-07-06Labeling · Supplement 23 · standardLetterAP
2006-11-29Labeling · Supplement 20 · standardLabelAP
2006-08-25Labeling · Supplement 11 · standardLetterAP
2006-02-23Labeling · Supplement 16 · standardLetterAP
2006-02-16Labeling · Supplement 9 · standardAP
2006-02-16Labeling · Supplement 13 · standardAP
2005-09-13Labeling · Supplement 15 · standardLetterAP
2001-10-24Manufacturing (CMC) · Supplement 3 · standardAP
2000-04-06Type 3 - New Dosage Form · Original · standardLetterAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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