Drugs@FDA: FDA-Approved Drugs
Company: MERCK
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
HYDROPRES 25 | HYDROCHLOROTHIAZIDE; RESERPINE | 25MG;0.125MG | TABLET;ORAL | Discontinued | None | No | No |
HYDROPRES 50 | HYDROCHLOROTHIAZIDE; RESERPINE | 50MG;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 |
---|---|---|---|---|---|---|---|
05/16/1974 | 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 |
---|---|---|---|---|---|
04/05/2002 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
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12/16/1994 | SUPPL-56 | Labeling |
Label is not available on this site. |
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05/23/1995 | SUPPL-55 | Labeling |
Label is not available on this site. |
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03/16/1994 | SUPPL-54 | Manufacturing (CMC) |
Label is not available on this site. |
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12/02/1993 | SUPPL-53 | Labeling |
Label is not available on this site. |
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10/01/1992 | SUPPL-52 | Labeling |
Label is not available on this site. |
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09/17/1992 | SUPPL-51 | Labeling |
Label is not available on this site. |
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09/18/1991 | SUPPL-50 | Labeling |
Label is not available on this site. |
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04/22/1988 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/01/1988 | SUPPL-48 | Labeling |
Label is not available on this site. |
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08/26/1987 | SUPPL-46 | Labeling |
Label is not available on this site. |
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08/15/1988 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |