Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011635
Company: MERCK
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIUPRES-250 | CHLOROTHIAZIDE; RESERPINE | 250MG;0.125MG | TABLET;ORAL | Discontinued | None | No | No |
| DIUPRES-500 | CHLOROTHIAZIDE; RESERPINE | 500MG;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 |
|---|---|---|---|---|---|---|---|
| 12/11/1958 | 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 |
|---|---|---|---|---|---|
| 12/16/1994 | SUPPL-45 | Labeling |
Label is not available on this site. |
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| 03/16/1994 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/17/1992 | SUPPL-43 | Labeling |
Label is not available on this site. |
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| 07/07/1994 | SUPPL-42 | Labeling |
Label is not available on this site. |
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| 07/01/1988 | SUPPL-41 | Labeling |
Label is not available on this site. |
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| 04/07/1988 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/26/1987 | SUPPL-39 | Labeling |
Label is not available on this site. |
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| 12/31/1987 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |