APPLICATION
ANDA204117
TYPE
ANDA
ORIGINAL APPROVAL
2016-12-27
LATEST ACTION
2025-03-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
ZIPRASIDONE HYDROCHLORIDEPrescription
ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE · CAPSULE · ORAL
ZIPRASIDONE HYDROCHLORIDEPrescription
ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE · CAPSULE · ORAL
ZIPRASIDONE HYDROCHLORIDEPrescription
ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE · CAPSULE · ORAL
ZIPRASIDONE HYDROCHLORIDEPrescription
ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE · CAPSULE · ORAL
Approval history
2025-03-18Labeling · Supplement 17 · standardAP
2025-03-18Labeling · Supplement 18 · standardAP
2023-10-24Labeling · Supplement 15 · standardAP
2019-11-29Labeling · Supplement 3 · standardAP
2019-11-29Labeling · Supplement 1 · standardAP
2016-12-27UNKNOWN · OriginalAP
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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