ANDA 75393, held by Teva Pharms USA. Haloperidol Decanoate.
As of Nov 14, 2026, ANDA 75393 (Haloperidol Decanoate), held by Teva Pharms USA, was first approved by FDA on May 11, 1999, with 13 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 11, 1999 | Original application | Approved |
| Haloperidol DecanoateEQ 50MG BASE/ML · injectable;injection | Haloperidol Decanoate | Discontinued |
| Haloperidol DecanoateEQ 100MG BASE/ML · injectable;injection | Haloperidol Decanoate | Discontinued |
| Aug 23, 2021 | Supplement 36Labeling · Standard review | Approved | None posted |
| Jun 25, 2020 | Supplement 33Labeling · Standard review | Approved | None posted |
| Aug 12, 2019 | Supplement 32Manufacturing | Approved | None posted |
| Aug 12, 2019 | Supplement 31Labeling · Standard review | Approved | None posted |
| Aug 12, 2019 | Supplement 30Labeling · Standard review | Approved | None posted |
| Aug 12, 2019 | Supplement 28Labeling · Standard review | Approved | None posted |
| Aug 12, 2019 | Supplement 26Labeling · Standard review | Approved | None posted |
| Jan 5, 2016 | Supplement 24Labeling · Standard review | Approved | None posted |
| May 1, 2012 | Supplement 19Labeling | Approved | None posted |
| May 6, 2010 | Supplement 8Labeling | Approved | None posted |
| Apr 30, 2009 | Supplement 6Labeling | Approved | None posted |
| Jun 13, 2006 | Supplement 4Labeling | Approved | None posted |
| Jul 30, 2003 | Supplement 1Labeling | Approved | None posted |
| May 11, 1999 | 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
