← FDA DRUG APPROVALS

FDA NDA · NDA022173

ZYPREXA RELPREVV

olanzapine pamoate

Sponsor: CHEPLAPHARM

APPLICATION
NDA022173
TYPE
NDA
ORIGINAL APPROVAL
2009-12-11
LATEST ACTION
2026-05-07
ROUTE
INTRAMUSCULAR
DOSAGE FORM
SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

ZYPREXA RELPREVV · ReferencePrescription
OLANZAPINE PAMOATE EQ 405MG BASE/VIAL · SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR
ZYPREXA RELPREVV · ReferencePrescription
OLANZAPINE PAMOATE EQ 210MG BASE/VIAL · SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR
ZYPREXA RELPREVV · ReferencePrescription
OLANZAPINE PAMOATE EQ 300MG BASE/VIAL · SUSPENSION, EXTENDED RELEASE · INTRAMUSCULAR

Approval history

2026-05-07Labeling · Supplement 43 · standard — Letter ↗AP
2026-05-07REMS · Supplement 40 — Letter ↗AP
2026-01-30Labeling · Supplement 50 · standard — Letter ↗AP
2025-01-22Labeling · Supplement 47 · standard — Label ↗AP
2021-04-28REMS · Supplement 39 — Letter ↗AP
2021-01-13Labeling · Supplement 37 · standard — Letter ↗AP
2020-04-23Labeling · Supplement 34 · standard — Label ↗AP
2020-04-22REMS · Supplement 35 — Letter ↗AP
2020-04-21Labeling · Supplement 36 · 901 required — Letter ↗AP
2019-10-22Labeling · Supplement 30 · standard — Letter ↗AP
2019-04-11REMS · Supplement 32 — Label ↗AP
2018-03-27Labeling · Supplement 29 · standard — Label ↗AP
2017-11-30REMS · Supplement 27 — Label ↗AP
2017-02-23Labeling · Supplement 28 · 901 required — Label ↗AP
2017-02-23Labeling · Supplement 26 · standard — Label ↗AP
2016-10-06Labeling · Supplement 25 · 901 required — Letter ↗AP
2015-12-23Manufacturing (CMC) · Supplement 19 · standardAP
2015-09-17Labeling · Supplement 24 · standard — Letter ↗AP
2015-07-23Labeling · Supplement 17 · standard — Label ↗AP
2014-12-19Labeling · Supplement 15 · standard — Label ↗AP
2014-10-30REMS · Supplement 23 — Label ↗AP
2014-02-18Manufacturing (CMC) · Supplement 20 · standardAP
2013-03-27REMS · Supplement 18 — Label ↗AP
2012-08-03REMS · Supplement 10 — Letter ↗AP
2012-08-03REMS · Supplement 8 — Letter ↗AP
2012-08-03REMS · Supplement 14 — Label ↗AP
2010-12-01Labeling · Supplement 9 · 901 required — Label ↗AP
2010-07-08REMS · Supplement 4 — Letter ↗AP
2010-05-27Labeling · Supplement 6 · unknown — Label ↗AP
2010-05-27Labeling · Supplement 3 · unknown — Label ↗AP
2010-04-27Labeling · Supplement 2 · unknown — Letter ↗AP
2009-12-11Type 3 - New Dosage Form · Original · standard — Other Important Information from FDA ↗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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