Drugs@FDA: FDA-Approved Drugs
Company: WYETH AYERST
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DIMETANE-TEN | BROMPHENIRAMINE MALEATE | 10MG/ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
09/29/1958 | 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 |
---|---|---|---|---|---|
06/03/1992 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/16/1988 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/13/1986 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/06/1984 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/18/1981 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/06/1981 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/21/1980 | SUPPL-17 | Labeling |
Label is not available on this site. |
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02/01/1980 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/26/1979 | SUPPL-15 | Labeling |
Label is not available on this site. |
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06/26/1979 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/07/1978 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/15/1978 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/26/1977 | SUPPL-11 | Labeling |
Label is not available on this site. |