Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050560
Company: ASTELLAS
Company: ASTELLAS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CEFIZOX | CEFTIZOXIME SODIUM | EQ 500MG BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
CEFIZOX | CEFTIZOXIME SODIUM | EQ 1GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
CEFIZOX | CEFTIZOXIME SODIUM | EQ 2GM BASE/VIAL | INJECTABLE;INJECTION | Discontinued | None | No | No |
CEFIZOX | CEFTIZOXIME SODIUM | EQ 10GM 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 |
---|---|---|---|---|---|---|---|
09/15/1983 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
---|---|---|---|---|---|
08/07/2000 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
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01/14/2005 | SUPPL-51 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/50560s051,50589s013ltr.pdf |
02/13/1996 | SUPPL-50 | Labeling |
Label is not available on this site. |
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12/14/1995 | SUPPL-49 | Labeling |
Label is not available on this site. |
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07/10/1995 | SUPPL-48 | Manufacturing (CMC) |
Label is not available on this site. |
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03/19/1993 | SUPPL-46 | Labeling |
Label is not available on this site. |
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01/22/1992 | SUPPL-43 | Labeling |
Label is not available on this site. |
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05/05/1989 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/23/1992 | SUPPL-36 | Efficacy-New Indication |
Label is not available on this site. |
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04/29/1987 | SUPPL-33 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |