Controls severe nausea and vomiting. ANDA 40058, held by Cosette Pharms Nc. Prochlorperazine.
As of Nov 13, 2026, ANDA 40058 (Prochlorperazine), held by Cosette Pharms Nc, was first approved by FDA on Nov 24, 1993, with 11 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Prochlorperazine Suppositories, USP 25 mg are indicated in the control of severe nausea and vomiting in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 24, 1993 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prochlorperazine25MG · suppository;rectal | Prochlorperazine | Rx |
| Jan 22, 2025 | Supplement 26Labeling · Standard review | Approved | None posted |
| Feb 23, 2017 | Supplement 21Labeling · Standard review | Approved | None posted |
| Oct 21, 2011 | Supplement 15Labeling | Approved | None posted |
| Dec 3, 2010 | Supplement 14Labeling | Approved | None posted |
| Jul 30, 2010 | Supplement 13Labeling | Approved | None posted |
| Jun 29, 2009 | Supplement 11Labeling | Approved | None posted |
| Sep 11, 2008 | Supplement 10Labeling | Approved | None posted |
| Sep 3, 2008 | Supplement 8Labeling | Approved | None posted |
| Jun 18, 2004 | Supplement 6Labeling | Approved | None posted |
| Nov 29, 1999 | Supplement 2Manufacturing | Approved | None posted |
| Apr 7, 1997 | Supplement 1Manufacturing | Approved | None posted |
| Nov 24, 1993 | 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
