Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050462
Company: WYETH AYERST
Company: WYETH AYERST
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| UNIPEN | NAFCILLIN SODIUM | EQ 500MG BASE | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 10/16/1973 | 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 |
|---|---|---|---|---|---|
| 08/03/1982 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/30/1980 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 04/24/1978 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/22/1977 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 06/02/1977 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 04/21/1976 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 03/23/1975 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 08/19/1975 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 11/22/1976 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 04/11/1974 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/08/1974 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 03/08/1974 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 04/10/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 09/28/1987 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 01/20/1987 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 12/05/1986 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 11/21/1986 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/28/1982 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 12/14/1982 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |