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FDA ANDA · ANDA077742
OLANZAPINE AND FLUOXETINE
olanzapine and fuoxetine
Sponsor: PH HEALTH
APPLICATION
ANDA077742
TYPE
ANDA
ORIGINAL APPROVAL
2012-11-02
LATEST ACTION
2026-01-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
OLANZAPINE AND FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 50MG BASE, OLANZAPINE EQ 6MG BASE · CAPSULE · ORAL
OLANZAPINE AND FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 25MG BASE, OLANZAPINE EQ 6MG BASE · CAPSULE · ORAL
OLANZAPINE AND FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 50MG BASE, OLANZAPINE EQ 12MG BASE · CAPSULE · ORAL
OLANZAPINE AND FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 25MG BASE, OLANZAPINE EQ 12MG BASE · CAPSULE · ORAL
OLANZAPINE AND FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 25MG BASE, OLANZAPINE EQ 3MG BASE · CAPSULE · ORAL
Approval history
2026-01-30Labeling · Supplement 24 · standardAP
2026-01-13Labeling · Supplement 23 · standardAP
2024-01-16Labeling · Supplement 21 · standardAP
2023-05-01Labeling · Supplement 19 · standardAP
2021-02-04Labeling · Supplement 18 · standardAP
2021-02-04Labeling · Supplement 12 · standardAP
2021-02-04Labeling · Supplement 11 · standardAP
2015-10-05Labeling · Supplement 9 · standardAP
2013-03-14Labeling · Supplement 2 · standardAP
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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