Helps diagnose pancreatic exocrine dysfunction. NDA 21256, held by Chirhoclin. Secretin Synthetic Human.
As of Nov 14, 2026, NDA 21256 (Chirhostim), held by Chirhoclin, was first approved by FDA on Apr 9, 2004, with 5 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE ChiRhoStim is indicated for the stimulation of: pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction. gastrin secretion to aid in the diagnosis of gastrinoma, and pancreatic secretions to facilitate the identification of the ampulla of Vater and accessory papilla during endoscopic retrograde cholangiopancreatography (ERCP).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 9, 2004 | Original applicationNew molecular entity · Priority review | Approved |
| Chirhostim16MCG/VIAL · for solution;intravenous | Secretin Synthetic Human | RxReference drug |
| Chirhostim40MCG/VIAL · for solution;intravenous | Secretin Synthetic Human | RxReference drug |
| Jul 18, 2017 | Supplement 13Labeling · Standard review | Approved | |
| Jul 28, 2015 | Supplement 12Manufacturing · Priority review | Approved | None posted |
| Jun 21, 2007 | Supplement 2Labeling · Standard review | Approved | |
| Jun 21, 2007 | Supplement 4Manufacturing · Priority review | Approved | |
| Sep 7, 2004 | Supplement 1Labeling · Standard review | Approved | |
| Apr 9, 2004 | Original applicationNew molecular entity · Priority review | 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
