ANDA 62750, held by Wyeth Pharms Inc. Piperacillin Sodium.
As of Nov 15, 2026, ANDA 62750 (Pipracil), held by Wyeth Pharms Inc, was first approved by FDA on Oct 13, 1987, with 13 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 13, 1987 | Original application | Approved | None posted |
| PipracilEQ 2GM BASE/VIAL · injectable;injection | Piperacillin Sodium | Discontinued |
| PipracilEQ 3GM BASE/VIAL · injectable;injection | Piperacillin Sodium | Discontinued |
| PipracilEQ 4GM BASE/VIAL · injectable;injection | Piperacillin Sodium | Discontinued |
| Oct 31, 2002 | Supplement 17Manufacturing | Approved | None posted |
| Oct 31, 2002 | Supplement 16Labeling | Approved | None posted |
| Oct 25, 2002 | Supplement 19Manufacturing | Approved | None posted |
| Oct 15, 2002 | Supplement 20Manufacturing | Approved | None posted |
| Mar 27, 2002 | Supplement 18Manufacturing | Approved | None posted |
| Oct 12, 2001 | Supplement 13Manufacturing | Approved | None posted |
| Dec 27, 2000 | Supplement 10Manufacturing | Approved | None posted |
| Feb 22, 1999 | Supplement 8Manufacturing | Approved | None posted |
| Jul 29, 1998 | Supplement 9Manufacturing | Approved | None posted |
| Dec 15, 1995 | Supplement 7Manufacturing | Approved | None posted |
| Oct 30, 1992 | Supplement 6Manufacturing | Approved | None posted |
| Jan 21, 1992 | Supplement 5Manufacturing | Approved | None posted |
| Oct 4, 1989 | Supplement 3Manufacturing | Approved | None posted |
| Oct 13, 1987 | Original application | 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
