Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 062732
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| 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 |
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 |
|---|---|---|---|---|---|
| 08/07/2020 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/07/2020 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/03/2016 | SUPPL-15 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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| 10/29/2013 | SUPPL-13 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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| 01/03/2016 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 09/13/2004 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 03/26/1996 | SUPPL-3 | 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. |