Controls severe nausea and vomiting. ANDA 40246, held by Padagis US. Prochlorperazine.
As of Nov 13, 2026, ANDA 40246 (Compro), held by Padagis US, was first approved by FDA on Jun 28, 2000, with 8 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Prochlorperazine 25 mg suppositories are indicated in the control of severe nausea and vomiting in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 28, 2000 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Compro25MG · suppository;rectal | Prochlorperazine | Rx |
| Jan 22, 2025 | Supplement 18Labeling · Standard review | Approved | None posted |
| Feb 23, 2017 | Supplement 14Labeling · Standard review | Approved | None posted |
| Oct 25, 2011 | Supplement 13Labeling | Approved | None posted |
| Dec 3, 2010 | Supplement 12Labeling | Approved | None posted |
| Jul 7, 2009 | Supplement 8Labeling | Approved | None posted |
| Mar 3, 2009 | Supplement 7Labeling | Approved | None posted |
| May 15, 2008 | Supplement 6Labeling | Approved | None posted |
| Feb 9, 2001 | Supplement 1Manufacturing | Approved | None posted |
| Jun 28, 2000 | 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
