Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071969
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 50MG;75MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/14/1988 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/25/2001 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/07/1999 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/13/1997 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 01/07/1993 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 09/28/1992 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 03/27/1991 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 02/04/1991 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 01/28/1991 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/07/1991 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/29/1990 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/18/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 10/18/1991 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/18/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/16/1988 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 03/16/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |