ANDA 77560, held by Lupin Pharms. Ziprasidone Hydrochloride.
As of Nov 15, 2026, ANDA 77560 (Ziprasidone Hydrochloride), held by Lupin Pharms, was first approved by FDA on Mar 2, 2012, with 10 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 2, 2012 | Original application | Approved |
| Ziprasidone HydrochlorideEQ 20MG BASE · capsule;oral | Ziprasidone Hydrochloride | Discontinued |
| Ziprasidone HydrochlorideEQ 40MG BASE · capsule;oral | Ziprasidone Hydrochloride | Discontinued |
| Ziprasidone HydrochlorideEQ 60MG BASE · capsule;oral | Ziprasidone Hydrochloride | Discontinued |
| Ziprasidone HydrochlorideEQ 80MG BASE · capsule;oral | Ziprasidone Hydrochloride | Discontinued |
| Sep 30, 2025 | Supplement 25Labeling · Standard review | Approved | None posted |
| Mar 30, 2023 | Supplement 19Labeling · Standard review | Approved | None posted |
| Mar 30, 2023 | Supplement 21Labeling · Standard review | Approved | None posted |
| Mar 30, 2023 | Supplement 22Labeling · Standard review | Approved | None posted |
| Mar 26, 2021 | Supplement 18Labeling · Standard review | Approved | None posted |
| Mar 26, 2021 | Supplement 17Labeling · Standard review | Approved | None posted |
| Mar 26, 2021 | Supplement 13Labeling · Standard review | Approved | None posted |
| Feb 23, 2016 | Supplement 11Labeling · Standard review | Approved | None posted |
| Mar 18, 2015 | Supplement 8Labeling · Standard review | Approved | None posted |
| Apr 24, 2014 | Supplement 5Labeling · Standard review | Approved | None posted |
| Mar 2, 2012 | Original application | Approved |
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
