Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 25MG;37.5MG | TABLET;ORAL | Prescription | AB | 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 |
---|---|---|---|---|---|---|---|
04/30/1992 | 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 |
---|---|---|---|---|---|
12/10/2020 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
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01/19/2012 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
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12/16/2002 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/25/2002 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/19/2002 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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10/25/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/08/2002 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/24/2000 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/01/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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12/01/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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09/09/1997 | SUPPL-6 | Labeling |
Label is not available on this site. |
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01/20/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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12/12/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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12/12/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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01/24/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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04/13/1993 | SUPPL-1 | Labeling |
Label is not available on this site. |
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
TABLET;ORAL; 25MG;37.5MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MAXZIDE-25 | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 25MG;37.5MG | TABLET;ORAL | Prescription | Yes | AB | 019129 | AUROBINDO PHARMA USA |
TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 25MG;37.5MG | TABLET;ORAL | Prescription | No | AB | 071251 | APOTEX INC |
TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 25MG;37.5MG | TABLET;ORAL | Prescription | No | AB | 216211 | RUBICON |
TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 25MG;37.5MG | TABLET;ORAL | Prescription | No | AB | 073281 | SANDOZ |
TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 25MG;37.5MG | TABLET;ORAL | Prescription | No | AB | 073449 | WATSON LABS |
TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 25MG;37.5MG | TABLET;ORAL | Prescription | No | AB | 208360 | ZYDUS PHARMS |