Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 011949
Company: SHIRE LLC
Company: SHIRE LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SALURON | HYDROFLUMETHIAZIDE | 50MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/22/1959 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 06/24/1996 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/02/1988 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 07/28/1986 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/1985 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/08/1984 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 01/09/1984 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 11/07/1983 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/27/1985 | SUPPL-18 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 11/07/1983 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/07/1983 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/29/1985 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 05/06/1980 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 11/14/1986 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/13/1979 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 01/30/1981 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/27/1978 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/29/1977 | SUPPL-9 | Labeling |
Label is not available on this site. |