Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 071851
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 | 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 |
|---|---|---|---|---|---|---|---|
| 11/30/1988 | 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 |
|---|---|---|---|---|---|
| 02/25/2022 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/11/2012 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/24/2002 | SUPPL-22 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/07/2002 | SUPPL-21 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/24/2002 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/05/2001 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/10/1999 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 11/15/1999 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1999 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 08/12/1997 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 06/08/1993 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/02/1992 | SUPPL-13 | Labeling |
Label is not available on this site. |
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| 05/12/1993 | SUPPL-9 | Bioequivalence |
Label is not available on this site. |
||
| 06/08/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 08/15/1990 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 06/08/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/08/1993 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/08/1993 | SUPPL-1 | Labeling |
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 | 216211 | RUBICON |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; TRIAMTERENE | 50MG;75MG | TABLET;ORAL | Prescription | No | AB | 072011 | SANDOZ |
| 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 |