NDA 20314, held by Curium. Indium In-111 Pentetreotide Kit.
As of Nov 14, 2026, NDA 20314 (Octreoscan), held by Curium, was first approved by FDA on Jun 2, 1994, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Octreoscan, after radiolabeling, is an agent for the scintigraphic localization of primary and metastatic neuroendocrine tumors bearing somatostatin receptors.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 2, 1994 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Octreoscan3mCi/ML · injectable;injection | Indium In-111 Pentetreotide Kit | RxReference drug |
| Feb 9, 2022 | Supplement 12Labeling · Standard review | Approved | |
| Dec 22, 2021 | Supplement 14Labeling · Standard review | Approved | |
| Apr 8, 1998 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Dec 8, 1994 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Jun 2, 1994 | Original applicationNew molecular entity · Priority review | 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
