Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 010971
Company: WYETH AYERST
Company: WYETH AYERST
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PMB 200 | ESTROGENS, CONJUGATED; MEPROBAMATE | 0.45MG;200MG | TABLET;ORAL | Discontinued | None | No | No |
PMB 400 | ESTROGENS, CONJUGATED; MEPROBAMATE | 0.45MG;400MG | 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 |
---|---|---|---|---|---|---|---|
05/31/1957 | ORIG-1 | Approval | Type 4 - New Combination | 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 |
---|---|---|---|---|---|
06/27/1996 | SUPPL-48 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/27/1995 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/23/1990 | SUPPL-44 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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12/20/1988 | SUPPL-43 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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09/07/1995 | SUPPL-42 | Labeling |
Label is not available on this site. |
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05/17/1987 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/11/1986 | SUPPL-39 | Labeling |
Label is not available on this site. |