APPLICATION
ANDA077565
TYPE
ANDA
ORIGINAL APPROVAL
2012-03-02
LATEST ACTION
2025-09-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ZIPRASIDONE HYDROCHLORIDEPrescription
ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE · CAPSULE · ORAL
ZIPRASIDONE HYDROCHLORIDEPrescription
ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE · CAPSULE · ORAL
ZIPRASIDONE HYDROCHLORIDEPrescription
ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE · CAPSULE · ORAL
ZIPRASIDONE HYDROCHLORIDEPrescription
ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE · CAPSULE · ORAL
Approval history
2025-09-17Labeling · Supplement 26 · standardAP
2023-03-30Labeling · Supplement 19 · standardAP
2023-03-30Labeling · Supplement 22 · standardAP
2021-11-02Labeling · Supplement 18 · standardAP
2021-11-02Labeling · Supplement 14 · standardAP
2019-11-29Labeling · Supplement 11 · standardAP
2019-11-29Labeling · Supplement 12 · standardAP
2015-11-19Labeling · Supplement 8 · standardAP
2015-04-13Labeling · Supplement 6 · standardAP
2013-09-19Labeling · Supplement 4 · standardAP
2013-07-25Labeling · Supplement 3 · standardAP
2012-03-22Labeling · Supplement 1AP
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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