Drugs@FDA: FDA-Approved Drugs
Company: WYETH CONS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DIMETANE | BROMPHENIRAMINE MALEATE | 4MG | TABLET;ORAL | Discontinued | None | No | No |
DIMETANE | BROMPHENIRAMINE MALEATE | 8MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
DIMETANE | BROMPHENIRAMINE MALEATE | 12MG | TABLET, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
08/23/1957 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | 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 |
---|---|---|---|---|---|
04/14/1998 | SUPPL-73 | Manufacturing (CMC) |
Label is not available on this site. |
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04/30/1996 | SUPPL-71 | Labeling |
Label is not available on this site. |
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02/06/1996 | SUPPL-70 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/03/1992 | SUPPL-69 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/24/1989 | SUPPL-68 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/24/1989 | SUPPL-67 | Labeling |
Label is not available on this site. |
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03/24/1988 | SUPPL-66 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/17/1988 | SUPPL-65 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/17/1986 | SUPPL-64 | Labeling |
Label is not available on this site. |
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06/10/1986 | SUPPL-63 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/28/1985 | SUPPL-62 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/24/1985 | SUPPL-60 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/17/1984 | SUPPL-59 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/19/1984 | SUPPL-58 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/15/1983 | SUPPL-57 | Efficacy |
Label is not available on this site. |
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04/15/1983 | SUPPL-56 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/17/1984 | SUPPL-53 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/10/1986 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/04/1986 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/10/1983 | SUPPL-35 | Labeling |
Label is not available on this site. |
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06/10/1983 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |