Ziprasidone Hydrochloride

ANDA 77562, held by Sandoz Inc. Ziprasidone Hydrochloride.

As of Nov 15, 2026, ANDA 77562 (Ziprasidone Hydrochloride), held by Sandoz Inc, was first approved by FDA on Jun 1, 2012, with 7 approved supplements and 0 published complete response letters.

First approved: Jun 1, 2012
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Jun 1, 2012	Original application	Approved	Letter

Products

4 strengths and forms


Ziprasidone HydrochlorideEQ 20MG BASE · capsule;oral	Ziprasidone Hydrochloride	Rx
Ziprasidone HydrochlorideEQ 40MG BASE · capsule;oral	Ziprasidone Hydrochloride	Rx
Ziprasidone HydrochlorideEQ 60MG BASE · capsule;oral	Ziprasidone Hydrochloride	Rx
Ziprasidone HydrochlorideEQ 80MG BASE · capsule;oral	Ziprasidone Hydrochloride	Rx

All 8 submissions, including labeling and manufacturing supplements


Nov 29, 2019	Supplement 12Labeling · Standard review	Approved	None posted
Nov 29, 2019	Supplement 14Labeling · Standard review	Approved	None posted
Dec 4, 2015	Supplement 11Labeling · Standard review	Approved	None posted
Mar 18, 2015	Supplement 7Labeling · Standard review	Approved	None posted
Mar 18, 2015	Supplement 9Labeling · Standard review	Approved	None posted
Mar 18, 2015	Supplement 10Labeling · Standard review	Approved	None posted
May 2, 2014	Supplement 2Manufacturing	Approved	None posted
Jun 1, 2012	Original application	Approved	Letter

Identifiers

Application: ANDA 77562
Drugs@FDA: Overview at FDA
Company: Sandoz

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters