Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065204
Company: SANDOZ INC
Company: SANDOZ INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFTRIAXONE | CEFTRIAXONE SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
| CEFTRIAXONE | CEFTRIAXONE 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 |
|---|---|---|---|---|---|---|---|
| 05/03/2005 | 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 |
|---|---|---|---|---|---|
| 01/13/2022 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/11/2020 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/05/2016 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/05/2016 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/05/2016 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/13/2011 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/31/2010 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/14/2009 | SUPPL-3 | Labeling |
Label is not available on this site. |