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 | 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 |
|---|---|---|---|---|---|---|---|
| 06/17/1988 | 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 |
|---|---|---|---|---|---|
| 12/10/2020 | SUPPL-39 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/19/2012 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/25/2002 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/05/2002 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/08/2001 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/22/2001 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/24/2000 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/05/1999 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/24/1999 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 06/24/1999 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 10/21/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/01/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/13/1993 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 05/15/1992 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 04/29/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 02/05/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 03/28/1991 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 05/01/1989 | 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 |