Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 064035
Company: WATSON LABS INC
Company: WATSON LABS INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFUROXIME SODIUM | CEFUROXIME SODIUM | EQ 750MG BASE/VIAL | INJECTABLE;INTRAMUSCULAR, INTRAVENOUS | Discontinued | None | No | No |
| CEFUROXIME SODIUM | CEFUROXIME SODIUM | EQ 1.5GM 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 |
|---|---|---|---|---|---|---|---|
| 02/26/1993 | 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 |
|---|---|---|---|---|---|
| 12/08/2000 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/04/1998 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/23/1998 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/20/1997 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/04/1996 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/04/1996 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/10/1996 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 07/02/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/06/1996 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 10/26/1995 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/27/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/18/1994 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/13/1994 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 03/15/1994 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/15/1994 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/17/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/20/1993 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 08/13/1993 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |