Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011958
Company: MERCK
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. |