← FDA DRUG APPROVALS

FDA NDA · NDA021253

ZYPREXA INTRAMUSCULAR

olanzapine

Sponsor: CHEPLAPHARM

APPLICATION
NDA021253
TYPE
NDA
ORIGINAL APPROVAL
2004-03-29
LATEST ACTION
2026-01-30
ROUTE
INTRAMUSCULAR
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription

Products

ZYPREXA · ReferencePrescription
OLANZAPINE 10MG/VIAL · POWDER · INTRAMUSCULAR

Approval history

2026-01-30Labeling · Supplement 67 · standard — Letter ↗AP
2025-01-22Labeling · Supplement 66 · standard — Label ↗AP
2020-04-23Labeling · Supplement 61 · standard — Label ↗AP
2020-04-21Labeling · Supplement 62 · 901 required — Letter ↗AP
2019-10-22Labeling · Supplement 60 · standard — Letter ↗AP
2018-03-27Labeling · Supplement 59 · standard — Label ↗AP
2017-02-23Labeling · Supplement 58 · 901 required — Label ↗AP
2017-02-23Labeling · Supplement 57 · standard — Label ↗AP
2016-10-27Manufacturing (CMC) · Supplement 55AP
2016-10-06Labeling · Supplement 56 · 901 required — Letter ↗AP
2015-07-23Labeling · Supplement 49 · standard — Label ↗AP
2014-12-19Labeling · Supplement 48 · standard — Letter ↗AP
2014-09-30Manufacturing (CMC) · Supplement 44 · standardAP
2014-08-11Manufacturing (CMC) · Supplement 52 · standardAP
2010-12-01Labeling · Supplement 45 · 901 required — Letter ↗AP
2010-05-27Labeling · Supplement 39 · unknown — Letter ↗AP
2010-05-27Labeling · Supplement 43 · unknown — Letter ↗AP
2010-01-27Labeling · Supplement 37 · unknown — Letter ↗AP
2009-08-31Labeling · Supplement 36 · unknown — Letter ↗AP
2008-08-14Labeling · Supplement 33 · standard — Letter ↗AP
2007-07-06Labeling · Supplement 26 · standard — Label ↗AP
2006-11-29Labeling · Supplement 21 · standard — Letter ↗AP
2006-08-25Labeling · Supplement 6 · standard — Letter ↗AP
2006-02-23Labeling · Supplement 16 · standard — Letter ↗AP
2006-02-16Labeling · Supplement 4 · standard — Letter ↗AP
2006-02-16Labeling · Supplement 12 · standard — Letter ↗AP
2005-09-13Labeling · Supplement 15 · standard — Letter ↗AP
2004-03-29Type 3 - New Dosage Form · Original · standard — Review ↗AP
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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