ANDA 71015, held by Teva. Haloperidol Lactate.
As of Nov 15, 2026, ANDA 71015 (Haloperidol), held by Teva, was first approved by FDA on Aug 25, 1987, with 17 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 25, 1987 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| HaloperidolEQ 2MG BASE/ML ยท concentrate;oral | Haloperidol Lactate | Discontinued |
| Aug 30, 2001 | Supplement 17Manufacturing | Approved | None posted |
| Jul 7, 2000 | Supplement 16Manufacturing | Approved | None posted |
| Jul 8, 1997 | Supplement 15Manufacturing | Approved | None posted |
| Nov 2, 1994 | Supplement 12Manufacturing | Approved | None posted |
| Nov 2, 1994 | Supplement 13Manufacturing | Approved | None posted |
| Nov 2, 1994 | Supplement 14Manufacturing | Approved | None posted |
| Oct 21, 1993 | Supplement 6Manufacturing | Approved | None posted |
| Oct 21, 1993 | Supplement 7Manufacturing | Approved | None posted |
| Oct 21, 1993 | Supplement 8Manufacturing | Approved | None posted |
| Oct 21, 1993 | Supplement 9Manufacturing | Approved | None posted |
| Oct 21, 1993 | Supplement 10Manufacturing | Approved | None posted |
| Oct 21, 1993 | Supplement 11Manufacturing | Approved | None posted |
| Sep 8, 1993 | Supplement 5Manufacturing | Approved | None posted |
| Aug 29, 1989 | Supplement 3Manufacturing | Approved | None posted |
| Jun 12, 1989 | Supplement 4Labeling | Approved | None posted |
| Jan 27, 1989 | Supplement 1Manufacturing | Approved | None posted |
| Sep 22, 1988 | Supplement 2Labeling | Approved | None posted |
| Aug 25, 1987 | Original application | Approved | None posted |
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
