Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062527
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NAFCILLIN SODIUM | NAFCILLIN SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| NAFCILLIN SODIUM | NAFCILLIN SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| NAFCILLIN SODIUM | NAFCILLIN SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| NAFCILLIN SODIUM | NAFCILLIN SODIUM | EQ 10GM 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 |
|---|---|---|---|---|---|---|---|
| 08/02/1984 | 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 |
|---|---|---|---|---|---|
| 07/27/2020 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/04/2016 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/04/2016 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/04/2016 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/04/2016 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/04/2016 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 09/30/2004 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 08/26/1998 | SUPPL-13 | Labeling |
Label is not available on this site. |