NDA 21566, held by Takeda Pharms Na. Lansoprazole.
As of Nov 14, 2026, NDA 21566 (Prevacid Iv), held by Takeda Pharms Na, was first approved by FDA on May 27, 2004, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 27, 2004 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prevacid Iv30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;intravenous | Lansoprazole | DiscontinuedReference drug |
| Jul 31, 2009 | Supplement 5 | Approved | |
| May 16, 2007 | Supplement 4Labeling · Standard review | Approved | |
| Dec 29, 2006 | Supplement 2Labeling · Standard review | Approved | |
| Apr 5, 2005 | Supplement 1Labeling · Standard review | Approved | |
| May 27, 2004 | Original applicationNew dosage form · Standard 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
