Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011835
Company: MERCK
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDRODIURIL | HYDROCHLOROTHIAZIDE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| HYDRODIURIL | HYDROCHLOROTHIAZIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| HYDRODIURIL | HYDROCHLOROTHIAZIDE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 02/24/1959 | 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 |
|---|---|---|---|---|---|
| 01/10/2002 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/08/1997 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/09/1997 | SUPPL-61 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/05/1998 | SUPPL-60 | Labeling |
Label is not available on this site. |
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| 02/08/1996 | SUPPL-59 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 11/29/1995 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/26/1994 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/16/1994 | SUPPL-56 | Labeling |
Label is not available on this site. |
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| 06/29/1994 | SUPPL-55 | Labeling |
Label is not available on this site. |
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| 10/28/1992 | SUPPL-53 | Labeling |
Label is not available on this site. |
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| 10/28/1992 | SUPPL-51 | Labeling |
Label is not available on this site. |
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| 10/28/1992 | SUPPL-44 | Efficacy-New Dosing Regimen |
Label is not available on this site. |