Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065310
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| AMPICILLIN AND SULBACTAM | AMPICILLIN SODIUM; SULBACTAM SODIUM | EQ 2GM BASE/VIAL;EQ 1GM 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 |
|---|---|---|---|---|---|---|---|
| 07/25/2006 | 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 |
|---|---|---|---|---|---|
| 01/30/2026 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/22/2024 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/06/2021 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/29/2020 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/29/2020 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/12/2015 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/12/2015 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/31/2007 | SUPPL-2 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |