← FDA DRUG APPROVALS

FDA ANDA · ANDA202395

ZIPRASIDONE HYDROCHLORIDE

Sponsor: MYLAN

APPLICATION
ANDA202395
TYPE
ANDA
ORIGINAL APPROVAL
2013-10-10
LATEST ACTION
2015-12-07
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

2015-12-07Labeling · Supplement 2 · standardAP
2015-04-02Labeling · Supplement 1 · standardAP
2013-10-10UNKNOWN · OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →