Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010028
Company: WYETH AYERST
Company: WYETH AYERST
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EQUANIL | MEPROBAMATE | 400MG | TABLET;ORAL | Discontinued | None | No | No |
| EQUANIL | MEPROBAMATE | 200MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/26/1955 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 07/27/1988 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/27/1988 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/05/1988 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/02/1987 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 04/08/1986 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 01/16/1981 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 07/24/1979 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/30/1978 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 08/18/1977 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 11/09/1976 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 06/23/1975 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |