Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062737
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OXACILLIN SODIUM | OXACILLIN SODIUM | EQ 1GM BASE/VIAL | POWDER;INTRAVENOUS | Discontinued | None | No | No |
| OXACILLIN SODIUM | OXACILLIN SODIUM | EQ 2GM BASE/VIAL | POWDER;INTRAVENOUS | 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 |
|---|---|---|---|---|---|---|---|
| 12/23/1986 | 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 |
|---|---|---|---|---|---|
| 05/25/2016 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/25/2016 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/04/2004 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 03/26/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/30/1992 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/24/1990 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |