NDA 21749, held by Hameln. Pentetate Calcium Trisodium.
As of Nov 14, 2026, NDA 21749 (Pentetate Calcium Trisodium), held by Hameln, was first approved by FDA on Aug 11, 2004, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 11, 2004 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pentetate Calcium TrisodiumEQ 1GM BASE/5ML (EQ 200MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;inhalation, intravenous | Pentetate Calcium Trisodium | DiscontinuedReference drug |
| Jul 8, 2016 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Feb 16, 2015 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Mar 21, 2013 | Supplement 8Labeling · Standard review | Approved | |
| Aug 4, 2005 | Supplement 2Labeling · Standard review | Approved | |
| Aug 11, 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
