Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050637
Company: PHARMACIA AND UPJOHN
Company: PHARMACIA AND UPJOHN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ZEFAZONE | CEFMETAZOLE SODIUM | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
ZEFAZONE | CEFMETAZOLE SODIUM | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
12/11/1989 | 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 |
---|---|---|---|---|---|
07/30/1993 | SUPPL-8 | Labeling |
Label is not available on this site. |
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09/17/2001 | SUPPL-7 | Labeling |
Label is not available on this site. |
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09/17/2001 | SUPPL-6 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
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12/08/1993 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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07/30/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
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09/17/2001 | SUPPL-3 | Efficacy-New Indication |
Label is not available on this site. |
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09/29/1992 | SUPPL-1 | Efficacy-New Indication |
Label is not available on this site. |