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FDA ANDA · ANDA077562

ZIPRASIDONE HYDROCHLORIDE

Sponsor: SANDOZ INC

APPLICATION
ANDA077562
TYPE
ANDA
ORIGINAL APPROVAL
2012-06-01
LATEST ACTION
2019-11-29
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

2019-11-29Labeling · Supplement 14 · standardAP
2019-11-29Labeling · Supplement 12 · standardAP
2015-12-04Labeling · Supplement 11 · standardAP
2015-03-18Labeling · Supplement 10 · standardAP
2015-03-18Labeling · Supplement 9 · standardAP
2015-03-18Labeling · Supplement 7 · standardAP
2014-05-02Manufacturing (CMC) · Supplement 2 · unknownAP
2012-06-01Original — Other Important Information from FDA ↗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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