Drugs@FDA: FDA-Approved Drugs
Company: APOTEX INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 50MG;75MG | TABLET;ORAL | Prescription | AB | No | No |
| 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 |
|---|---|---|---|---|---|---|---|
| 12/08/1987 | 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-48 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/19/2012 | SUPPL-41 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/29/2009 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 03/13/2002 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/27/2000 | SUPPL-28 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/21/1999 | SUPPL-27 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/20/1999 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/1999 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/08/1998 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/05/1998 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/05/1998 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/05/1998 | SUPPL-20 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
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| 05/05/1998 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 06/23/1997 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 04/07/1997 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/02/1995 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/23/1995 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1994 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/11/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/1993 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 10/05/1992 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/26/1989 | SUPPL-6 | Bioequivalence |
Label is not available on this site. |
||
| 10/20/1989 | SUPPL-5 | Bioequivalence |
Label is not available on this site. |
||
| 12/03/1991 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 05/06/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/02/1988 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/06/1988 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
TABLET;ORAL; 50MG;75MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| MAXZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 50MG;75MG | TABLET;ORAL | Prescription | Yes | AB | 019129 | AUROBINDO PHARMA USA |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 50MG;75MG | TABLET;ORAL | Prescription | No | AB | 071251 | APOTEX INC |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 50MG;75MG | TABLET;ORAL | Prescription | No | AB | 072011 | CHARTWELL RX |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 50MG;75MG | TABLET;ORAL | Prescription | No | AB | 216211 | RUBICON |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 50MG;75MG | TABLET;ORAL | Prescription | No | AB | 071851 | WATSON LABS |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 50MG;75MG | TABLET;ORAL | Prescription | No | AB | 208360 | ZYDUS PHARMS |
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 |