Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050509
Company: WYETH AYERST
Company: WYETH AYERST
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYCLAPEN-W | CYCLACILLIN | 250MG | TABLET;ORAL | Discontinued | None | No | No |
| CYCLAPEN-W | CYCLACILLIN | 500MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/13/1979 | 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 |
|---|---|---|---|---|---|
| 07/08/1982 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/08/1982 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 04/30/1980 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/07/1980 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/30/1979 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/19/1979 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 01/20/1987 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/09/1985 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/12/1985 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/24/1984 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/13/1984 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |