NDA 11777, held by Mallinckrodt. Sodium Phosphate P-32.
As of Nov 14, 2026, NDA 11777 (Sodium Phosphate P 32), held by Mallinckrodt, was first approved by FDA on Mar 4, 1959, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 4, 1959 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Sodium Phosphate P 320.67mCi/ML · solution;injection, oral | Sodium Phosphate P-32 | Discontinued |
| Sodium Phosphate P 321.5mCi/VIAL · solution;injection, oral | Sodium Phosphate P-32 | Discontinued |
| Aug 28, 2001 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Apr 22, 1998 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Dec 20, 1994 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Oct 5, 1993 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| May 10, 1990 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| May 7, 1982 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Mar 31, 1980 | Supplement 13Labeling · Standard review | Approved | None posted |
| Nov 16, 1977 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Aug 23, 1977 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Jul 27, 1977 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Jan 24, 1977 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Mar 4, 1959 | Original applicationNew formulation or manufacturer · 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
