Drugs@FDA: FDA-Approved Drugs
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ESIDRIX | HYDROCHLOROTHIAZIDE | 25MG | TABLET;ORAL | Discontinued | None | No | No |
| ESIDRIX | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Discontinued | None | No | No |
| ESIDRIX | HYDROCHLOROTHIAZIDE | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/12/1959 | 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 |
|---|---|---|---|---|---|
| 04/29/2002 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/28/1999 | SUPPL-69 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 07/21/1997 | SUPPL-68 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/20/1996 | SUPPL-67 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/27/1996 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/31/1995 | SUPPL-65 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/01/1994 | SUPPL-64 | Labeling |
Label is not available on this site. |
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| 03/10/1993 | SUPPL-62 | Labeling |
Label is not available on this site. |
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| 06/05/1991 | SUPPL-61 | Labeling |
Label is not available on this site. |
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| 07/30/1992 | SUPPL-60 | Labeling |
Label is not available on this site. |
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| 11/09/1990 | SUPPL-59 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 09/23/1988 | SUPPL-58 | Labeling |
Label is not available on this site. |
||
| 10/02/1986 | SUPPL-57 | Labeling |
Label is not available on this site. |
||
| 03/19/1985 | SUPPL-56 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/08/1982 | SUPPL-55 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/23/1982 | SUPPL-54 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 06/04/1982 | SUPPL-53 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/10/1986 | SUPPL-51 | Labeling |
Label is not available on this site. |
||
| 02/02/1981 | SUPPL-50 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/30/1980 | SUPPL-49 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/17/1980 | SUPPL-48 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/29/1979 | SUPPL-47 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/29/1979 | SUPPL-46 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/29/1979 | SUPPL-45 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/10/1978 | SUPPL-44 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/16/1977 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/12/1977 | SUPPL-42 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/22/1978 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 02/09/1977 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 08/31/1976 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/09/1977 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 08/18/1976 | SUPPL-37 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/20/1976 | SUPPL-36 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/24/1976 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/09/1975 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 03/24/1976 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/02/1975 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/02/1975 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/02/1975 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |