Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018535
Company: GD SEARLE LLC
Company: GD SEARLE LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DIULO | METOLAZONE | 2.5MG | TABLET;ORAL | Discontinued | None | No | No |
| DIULO | METOLAZONE | 5MG | TABLET;ORAL | Discontinued | None | No | No |
| DIULO | METOLAZONE | 10MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/24/1981 | 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 |
|---|---|---|---|---|---|
| 11/28/1990 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 09/22/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 07/24/1986 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 01/11/1983 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 11/29/1982 | SUPPL-2 | Labeling |
Label is not available on this site. |