Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019046
Company: SCHERING
Company: SCHERING
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NORMOZIDE | HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE | 25MG;100MG | TABLET;ORAL | Discontinued | None | No | No |
| NORMOZIDE | HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE | 25MG;200MG | TABLET;ORAL | Discontinued | None | No | No |
| NORMOZIDE | HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE | 25MG;300MG | TABLET;ORAL | Discontinued | None | No | No |
| NORMOZIDE | HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE | 25MG;400MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/06/1987 | 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 |
|---|---|---|---|---|---|
| 11/07/1990 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 06/16/1989 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 06/16/1989 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 04/14/1988 | SUPPL-2 | Labeling |
Label is not available on this site. |