FDA ANDA · ANDA077301

OLANZAPINE

Sponsor: IVAX PHARMS INC

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APPLICATION
ANDA077301
TYPE
ANDA
ORIGINAL APPROVAL
2015-04-29
LATEST ACTION
2026-10-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

OLANZAPINEDiscontinued
OLANZAPINE 20MG · TABLET · ORAL

Approval history

2026-10-14Labeling · Supplement 5 · standardAP
2025-08-04Labeling · Supplement 1 · standardAP
2025-08-04Labeling · Supplement 4 · standardAP
2025-08-04Labeling · Supplement 2 · standardAP
2015-04-29OriginalAP