Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065224
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFTRIAXONE IN PLASTIC CONTAINER | CEFTRIAXONE SODIUM | EQ 20MG BASE/ML | INJECTABLE;INJECTION | Prescription | None | No | Yes |
| CEFTRIAXONE IN PLASTIC CONTAINER | CEFTRIAXONE SODIUM | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/23/2005 | 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 |
|---|---|---|---|---|---|
| 03/22/2024 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/13/2022 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/30/2013 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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| 06/18/2009 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 03/05/2008 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 09/12/2007 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 10/22/2007 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 04/24/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |