Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062798
Company: ISTITUTO BIO ITA SPA
Company: ISTITUTO BIO ITA SPA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OXACILLIN SODIUM | OXACILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| OXACILLIN SODIUM | OXACILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| OXACILLIN SODIUM | OXACILLIN SODIUM | EQ 125MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| OXACILLIN SODIUM | OXACILLIN SODIUM | EQ 250MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| OXACILLIN SODIUM | OXACILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/11/1995 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/07/2020 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |