Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073191
Company: CHARTWELL RX
Company: CHARTWELL RX
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 25MG;50MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 07/31/1991 | 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 |
|---|---|---|---|---|---|
| 04/18/2012 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/13/2008 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 01/05/2004 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 04/19/2002 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/06/2001 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/09/2001 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/27/2001 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/19/1999 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/01/1998 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/01/1998 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/01/1998 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/14/1999 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 04/14/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/24/1994 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/13/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/13/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/06/1995 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |