Drugs@FDA: FDA-Approved Drugs
Company: SHIRE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SALUTENSIN | HYDROFLUMETHIAZIDE; RESERPINE | 50MG;0.125MG | TABLET;ORAL | Discontinued | None | No | No |
SALUTENSIN-DEMI | HYDROFLUMETHIAZIDE; RESERPINE | 25MG;0.125MG | 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 |
---|---|---|---|---|---|---|---|
06/20/1960 | 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 |
---|---|---|---|---|---|
06/24/1996 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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10/07/1992 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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07/09/1990 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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06/22/1988 | SUPPL-29 | Labeling |
Label is not available on this site. |
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10/24/1986 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/27/1986 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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08/01/1985 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/29/1985 | SUPPL-25 | Labeling |
Label is not available on this site. |
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06/08/1984 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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08/23/1983 | SUPPL-23 | Labeling |
Label is not available on this site. |
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05/10/1984 | SUPPL-22 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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03/03/1982 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/03/1982 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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08/03/1981 | SUPPL-19 | Labeling |
Label is not available on this site. |
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07/29/1985 | SUPPL-18 | Labeling |
Label is not available on this site. |
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06/10/1982 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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07/31/1979 | SUPPL-16 | Labeling |
Label is not available on this site. |
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10/03/1980 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/03/1980 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/15/1978 | SUPPL-13 | Labeling |
Label is not available on this site. |
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05/15/1978 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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04/27/1978 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/15/1978 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/15/1978 | SUPPL-9 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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06/23/1977 | SUPPL-6 | Labeling |
Label is not available on this site. |
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12/13/1977 | SUPPL-5 | Unspecified |
Label is not available on this site. |
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06/23/1977 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |