APPLICATION
ANDA090348
TYPE
ANDA
ORIGINAL APPROVAL
2012-09-05
LATEST ACTION
2026-04-24
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
2026-04-24Labeling · Supplement 5 · standardAP
2026-04-24Labeling · Supplement 2 · standardAP
2015-02-04Labeling · Supplement 1 · standardAP
2012-09-05OriginalAP
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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