ANDA 62984, held by Chartwell Rx. Oxacillin Sodium.
As of Nov 15, 2026, ANDA 62984 (Oxacillin Sodium), held by Chartwell Rx, was first approved by FDA on Sep 29, 1988, with 15 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 29, 1988 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oxacillin SodiumEQ 10GM BASE/VIAL · injectable;injection | Oxacillin Sodium | Discontinued |
| Apr 4, 2016 | Supplement 17Labeling · Standard review | Approved | None posted |
| Dec 8, 2000 | Supplement 16Manufacturing | Approved | None posted |
| May 14, 1999 | Supplement 15Manufacturing | Approved | None posted |
| Sep 29, 1998 | Supplement 14Manufacturing | Approved | None posted |
| Dec 22, 1997 | Supplement 13Manufacturing | Approved | None posted |
| Jul 22, 1997 | Supplement 11Labeling | Approved | None posted |
| Feb 10, 1995 | Supplement 10Manufacturing | Approved | None posted |
| Jan 27, 1995 | Supplement 9Manufacturing | Approved | None posted |
| Mar 18, 1994 | Supplement 3Labeling | Approved | None posted |
| Jan 13, 1994 | Supplement 8Manufacturing | Approved | None posted |
| Nov 19, 1993 | Supplement 7Manufacturing | Approved | None posted |
| Nov 19, 1993 | Supplement 6Manufacturing | Approved | None posted |
| Mar 11, 1992 | Supplement 4Manufacturing | Approved | None posted |
| Nov 9, 1990 | Supplement 2Manufacturing | Approved | None posted |
| Dec 7, 1988 | Supplement 1Manufacturing | Approved | None posted |
| Sep 29, 1988 | 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
