Drugs@FDA: FDA-Approved Drugs
Company: WYETH AYERST
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| UNIPEN | NAFCILLIN SODIUM | EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| UNIPEN | NAFCILLIN SODIUM | EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| UNIPEN | NAFCILLIN SODIUM | EQ 4GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| UNIPEN | NAFCILLIN SODIUM | EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| UNIPEN | NAFCILLIN SODIUM | EQ 20GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| UNIPEN IN PLASTIC CONTAINER | NAFCILLIN SODIUM | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/23/1970 | 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 |
|---|---|---|---|---|---|
| 08/12/1982 | SUPPL-70 | Labeling |
Label is not available on this site. |
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| 05/12/1982 | SUPPL-69 | Labeling |
Label is not available on this site. |
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| 06/01/1981 | SUPPL-68 | Labeling |
Label is not available on this site. |
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| 06/01/1981 | SUPPL-67 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/08/1981 | SUPPL-66 | Labeling |
Label is not available on this site. |
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| 04/08/1981 | SUPPL-65 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/21/1980 | SUPPL-64 | Labeling |
Label is not available on this site. |
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| 08/20/1980 | SUPPL-63 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 07/30/1979 | SUPPL-62 | Labeling |
Label is not available on this site. |
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| 02/23/1979 | SUPPL-61 | Labeling |
Label is not available on this site. |
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| 02/23/1979 | SUPPL-60 | Labeling |
Label is not available on this site. |
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| 12/21/1978 | SUPPL-59 | Labeling |
Label is not available on this site. |
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| 12/21/1978 | SUPPL-58 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/28/1978 | SUPPL-57 | Labeling |
Label is not available on this site. |
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| 02/06/1978 | SUPPL-56 | Labeling |
Label is not available on this site. |
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| 12/22/1977 | SUPPL-55 | Labeling |
Label is not available on this site. |
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| 10/04/1977 | SUPPL-54 | Labeling |
Label is not available on this site. |
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| 01/19/1978 | SUPPL-53 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 01/19/1978 | SUPPL-52 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 08/10/1977 | SUPPL-51 | Labeling |
Label is not available on this site. |
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| 06/01/1977 | SUPPL-50 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/11/1977 | SUPPL-49 | Labeling |
Label is not available on this site. |
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| 06/20/1977 | SUPPL-47 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/11/1977 | SUPPL-46 | Labeling |
Label is not available on this site. |
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| 01/11/1977 | SUPPL-45 | Labeling |
Label is not available on this site. |
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| 09/23/1976 | SUPPL-44 | Labeling |
Label is not available on this site. |
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| 09/07/1976 | SUPPL-43 | Labeling |
Label is not available on this site. |
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| 09/07/1976 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/23/1976 | SUPPL-41 | Labeling |
Label is not available on this site. |
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| 03/23/1976 | SUPPL-40 | Labeling |
Label is not available on this site. |
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| 03/23/1976 | SUPPL-39 | Labeling |
Label is not available on this site. |
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| 02/13/1976 | SUPPL-38 | Labeling |
Label is not available on this site. |
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| 05/22/1975 | SUPPL-36 | Labeling |
Label is not available on this site. |
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| 08/19/1975 | SUPPL-35 | Labeling |
Label is not available on this site. |
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| 01/23/1975 | SUPPL-34 | Labeling |
Label is not available on this site. |
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| 08/02/1974 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 03/12/1974 | SUPPL-30 | Labeling |
Label is not available on this site. |
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| 01/24/1974 | SUPPL-29 | Labeling |
Label is not available on this site. |
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| 11/23/1973 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 11/19/1973 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 01/11/1972 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 12/06/1971 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 10/22/1971 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 09/24/1971 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/31/1972 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 05/19/1971 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 05/18/1971 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 04/02/1971 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 12/11/1970 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 08/10/1970 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 08/31/1988 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/20/1988 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 12/19/1988 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/22/1988 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 07/08/1987 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 04/14/1987 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/27/1985 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 07/29/1987 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/02/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/03/1985 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/19/1983 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/28/1982 | SUPPL-1 | Labeling |
Label is not available on this site. |