Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 063002
Company: BAXTER HLTHCARE
Company: BAXTER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ANCEF IN PLASTIC CONTAINER | CEFAZOLIN SODIUM | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| ANCEF IN PLASTIC CONTAINER | CEFAZOLIN SODIUM | EQ 20MG BASE/ML | 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 |
|---|---|---|---|---|---|---|---|
| 03/28/1991 | 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 |
|---|---|---|---|---|---|
| 02/29/2016 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/22/2013 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 04/30/2008 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 10/07/2004 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 03/06/2001 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/27/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/21/1992 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |