ANDA 61334, held by Glaxosmithkline. Oxacillin Sodium.
As of Nov 15, 2026, ANDA 61334 (Bactocill), held by Glaxosmithkline, was first approved by FDA on Mar 26, 1982, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 26, 1982 | Original application | Approved | None posted |
| BactocillEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Oxacillin Sodium | Discontinued |
| BactocillEQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Oxacillin Sodium | Discontinued |
| BactocillEQ 4GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Oxacillin Sodium | Discontinued |
| BactocillEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Oxacillin Sodium | Discontinued |
| BactocillEQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Oxacillin Sodium | Discontinued |
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
