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FDA ANDA · ANDA203708

OLANZAPINE

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA203708
TYPE
ANDA
ORIGINAL APPROVAL
2014-05-15
LATEST ACTION
2026-05-26
ROUTE
ORAL
DOSAGE FORM
TABLET, ORALLY DISINTEGRATING
MARKETING STATUS
Prescription

Products

OLANZAPINEPrescription
OLANZAPINE 20MG · TABLET, ORALLY DISINTEGRATING · ORAL
OLANZAPINEPrescription
OLANZAPINE 10MG · TABLET, ORALLY DISINTEGRATING · ORAL
OLANZAPINEPrescription
OLANZAPINE 15MG · TABLET, ORALLY DISINTEGRATING · ORAL
OLANZAPINEPrescription
OLANZAPINE 5MG · TABLET, ORALLY DISINTEGRATING · ORAL

Approval history

2026-05-26Labeling · Supplement 17 · standardAP
2026-05-26Labeling · Supplement 16 · standardAP
2021-11-03Labeling · Supplement 13 · standardAP
2021-11-03Labeling · Supplement 9 · standardAP
2021-11-03Labeling · Supplement 11 · standardAP
2021-11-03Labeling · Supplement 7 · standardAP
2021-11-03Labeling · Supplement 5 · standardAP
2021-11-03Labeling · Supplement 3 · standardAP
2021-11-03Labeling · Supplement 8 · standardAP
2021-11-03Labeling · Supplement 6 · standardAP
2015-04-13Labeling · Supplement 1 · standardAP
2014-05-15UNKNOWN · OriginalAP
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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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