Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 014122
Company: WYETH AYERST
Company: WYETH AYERST
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROTOPAM CHLORIDE | PRALIDOXIME CHLORIDE | 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 |
|---|---|---|---|---|---|---|---|
| 03/12/1964 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/24/1987 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 08/21/1985 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/03/1985 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 05/20/1985 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/16/1981 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/01/1979 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 10/01/1979 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/11/1974 | SUPPL-9 |
Label is not available on this site. |
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| 06/27/1974 | SUPPL-8 |
Label is not available on this site. |
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| 11/08/1974 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |