Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050589
Company: ASTELLAS
Company: ASTELLAS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER | CEFTIZOXIME SODIUM | EQ 20MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER | CEFTIZOXIME SODIUM | EQ 40MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| CEFIZOX IN PLASTIC CONTAINER | CEFTIZOXIME SODIUM | EQ 20MG BASE/ML | INJECTABLE;INJECTION | Discontinued | None | No | No |
| CEFIZOX IN PLASTIC CONTAINER | CEFTIZOXIME SODIUM | EQ 40MG 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 |
|---|---|---|---|---|---|---|---|
| 10/03/1984 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/14/2005 | SUPPL-13 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50560s051,50589s013ltr.pdf |
| 02/26/1996 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/24/1993 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 09/25/1992 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 04/13/1995 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 03/13/2009 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 02/06/1992 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/06/1992 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 03/13/2009 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 02/06/1992 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/12/1986 | SUPPL-3 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 07/15/1985 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 04/16/1985 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |