APPLICATION
ANDA204375
TYPE
ANDA
ORIGINAL APPROVAL
2017-02-17
LATEST ACTION
2023-06-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
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
ZIPRASIDONE HYDROCHLORIDEPrescription
ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE · CAPSULE · ORAL
Approval history
2023-06-07Labeling · Supplement 25 · standardAP
2020-09-09Labeling · Supplement 14 · standardAP
2020-09-09Labeling · Supplement 8 · standardAP
2020-09-09Labeling · Supplement 2 · standardAP
2017-02-17UNKNOWN · 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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