NDA 17707, held by Ge Healthcare. Indium In-111 Pentetate Disodium.
As of Nov 14, 2026, NDA 17707 (Mpi Indium Dtpa In 111), held by Ge Healthcare, was first approved by FDA on Feb 18, 1982, with 8 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Pentetate Indium Disodium In 111 is recommended for use in radionuclide cisternography.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 18, 1982 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mpi Indium Dtpa In 1111mCi/ML · injectable;intrathecal | Indium In-111 Pentetate Disodium | RxReference drug |
| Dec 22, 2016 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Sep 21, 2004 | Supplement 10Labeling · Standard review | Approved | |
| Apr 30, 2002 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Jan 30, 1996 | Supplement 7Labeling · Standard review | Approved | None posted |
| May 19, 1995 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Feb 28, 1995 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| May 22, 1985 | Supplement 3Labeling | Approved | None posted |
| Sep 27, 1984 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Feb 18, 1982 | Original applicationNew molecular entity · Standard 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
