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FDA ANDA · ANDA077561

ZIPRASIDONE HYDROCHLORIDE

ziprasidone hcl

Sponsor: APOTEX

APPLICATION
ANDA077561
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 21 · standardAP
2025-09-17Labeling · Supplement 22 · standardAP
2021-07-19Labeling · Supplement 19 · standardAP
2021-07-19Labeling · Supplement 18 · standardAP
2021-07-19Labeling · Supplement 14 · standardAP
2020-03-11Labeling · Supplement 12 · standardAP
2020-03-11Labeling · Supplement 10 · standardAP
2016-02-18Labeling · Supplement 7 · standardAP
2015-03-18Labeling · Supplement 6 · standardAP
2015-03-18Labeling · Supplement 3 · standardAP
2013-09-18Labeling · Supplement 2 · standardAP
2012-03-02Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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