Ziprasidone Hydrochloride

ANDA 208988, held by Zydus Lifesciences. Ziprasidone Hydrochloride.

As of Nov 15, 2026, ANDA 208988 (Ziprasidone Hydrochloride), held by Zydus Lifesciences, was first approved by FDA on Aug 22, 2017, with 2 approved supplements and 0 published complete response letters.

First approved: Aug 22, 2017
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Aug 22, 2017	Original application	Approved	None posted

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 3 submissions, including labeling and manufacturing supplements


Sep 15, 2020	Supplement 1Labeling · Standard review	Approved	None posted
Sep 15, 2020	Supplement 2Labeling · Standard review	Approved	None posted
Aug 22, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 208988
Drugs@FDA: Overview at FDA
Company: Zydus Lifesciences

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