APPLICATION
ANDA077528
TYPE
ANDA
ORIGINAL APPROVAL
2012-06-19
LATEST ACTION
2026-01-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
OLANZAPINE AND FLUOXETINE HYDROCHLORIDEPrescription
FLUOXETINE HYDROCHLORIDE EQ 25MG BASE, OLANZAPINE EQ 12MG BASE · CAPSULE · ORAL
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
Approval history
2026-01-30Labeling · Supplement 24 · standardAP
2026-01-14Labeling · Supplement 23 · standardAP
2025-01-29Labeling · Supplement 22 · standardAP
2021-11-24Labeling · Supplement 20 · standardAP
2021-11-24Labeling · Supplement 19 · standardAP
2021-02-26Labeling · Supplement 13 · standardAP
2021-02-26Labeling · Supplement 9 · standardAP
2021-02-26Labeling · Supplement 11 · standardAP
2021-02-26Labeling · Supplement 7 · standardAP
2021-02-26Labeling · Supplement 18 · standardAP
2021-02-26Labeling · Supplement 16 · standardAP
2021-02-26Labeling · Supplement 12 · standardAP
2021-02-26Labeling · Supplement 10 · standardAP
2021-02-26Labeling · Supplement 6 · standardAP
2014-12-19Labeling · Supplement 5 · standardAP
2014-12-19Labeling · Supplement 3 · standardAP
2014-12-19Labeling · Supplement 4 · standardAP
2013-04-22Labeling · Supplement 2 · standardAP
2012-12-31Labeling · Supplement 1 · 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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