NDA 21507, held by Takeda Pharms Na. Lansoprazole; Naproxen.
As of Nov 13, 2026, NDA 21507 (Prevacid Naprapac 250 (Copackaged), Prevacid Naprapac 375 (Copackaged), Prevacid Naprapac 500 (Copackaged)), held by Takeda Pharms Na, was first approved by FDA on Nov 14, 2003, with 5 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 14, 2003 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Prevacid Naprapac 250 (Copackaged)15MG,N/A;N/A,250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule, delayed rel pellets, tablet;oral | Lansoprazole; Naproxen | DiscontinuedReference drug |
| Prevacid Naprapac 375 (Copackaged)15MG,N/A;N/A,375MG · capsule, delayed rel pellets, tablet;oral | Lansoprazole; Naproxen | Discontinued |
| Prevacid Naprapac 500 (Copackaged)15MG,N/A;N/A,500MG · capsule, delayed rel pellets, tablet;oral | Lansoprazole; Naproxen | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 31, 2009 | Supplement 9 | Approved | |
| Oct 20, 2008 | Supplement 8Labeling · Standard review | Approved | |
| Aug 31, 2006 | Supplement 5Labeling · Standard review | Approved | |
| Aug 31, 2006 | Supplement 7Labeling · Standard review | Approved | |
| Apr 12, 2006 | Supplement 4Labeling · Standard review | Approved | |
| Nov 14, 2003 | Original applicationNew combination · 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
