APPLICATION
ANDA077560
TYPE
ANDA
ORIGINAL APPROVAL
2012-03-02
LATEST ACTION
2025-09-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
ZIPRASIDONE HYDROCHLORIDEDiscontinued
ZIPRASIDONE HYDROCHLORIDE EQ 60MG BASE · CAPSULE · ORAL
ZIPRASIDONE HYDROCHLORIDEDiscontinued
ZIPRASIDONE HYDROCHLORIDE EQ 20MG BASE · CAPSULE · ORAL
ZIPRASIDONE HYDROCHLORIDEDiscontinued
ZIPRASIDONE HYDROCHLORIDE EQ 80MG BASE · CAPSULE · ORAL
ZIPRASIDONE HYDROCHLORIDEDiscontinued
ZIPRASIDONE HYDROCHLORIDE EQ 40MG BASE · CAPSULE · ORAL
Approval history
2025-09-30Labeling · Supplement 25 · standardAP
2023-03-30Labeling · Supplement 22 · standardAP
2023-03-30Labeling · Supplement 19 · standardAP
2023-03-30Labeling · Supplement 21 · standardAP
2021-03-26Labeling · Supplement 18 · standardAP
2021-03-26Labeling · Supplement 17 · standardAP
2021-03-26Labeling · Supplement 13 · standardAP
2016-02-23Labeling · Supplement 11 · standardAP
2015-03-18Labeling · Supplement 8 · standardAP
2014-04-24Labeling · Supplement 5 · 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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