Drugs@FDA: FDA-Approved Drugs
Company: IVAX SUB TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 25MG | TABLET;ORAL | Prescription | AB | Yes | No |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/12/1973 | 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 |
|---|---|---|---|---|---|
| 08/20/2020 | SUPPL-229 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/19/2012 | SUPPL-221 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/07/2005 | SUPPL-205 | Labeling |
Label is not available on this site. |
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| 07/07/2004 | SUPPL-200 | Labeling |
Label is not available on this site. |
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| 07/29/2002 | SUPPL-197 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/15/2002 | SUPPL-196 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/12/2001 | SUPPL-195 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/22/2002 | SUPPL-193 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/03/2000 | SUPPL-192 | Labeling |
Label is not available on this site. |
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| 01/28/2000 | SUPPL-191 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 02/03/2000 | SUPPL-190 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/30/1999 | SUPPL-188 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/30/1999 | SUPPL-187 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/30/1999 | SUPPL-186 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/09/1998 | SUPPL-185 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/13/1998 | SUPPL-184 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/13/1998 | SUPPL-183 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/30/1997 | SUPPL-182 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/24/1996 | SUPPL-181 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/17/1995 | SUPPL-180 | Labeling |
Label is not available on this site. |
||
| 06/03/1993 | SUPPL-179 | Labeling |
Label is not available on this site. |
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| 03/12/1993 | SUPPL-178 | Labeling |
Label is not available on this site. |
||
| 10/06/1995 | SUPPL-177 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/1992 | SUPPL-176 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/1992 | SUPPL-175 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/10/1988 | SUPPL-174 | Bioequivalence |
Label is not available on this site. |
||
| 03/31/1988 | SUPPL-170 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/31/1988 | SUPPL-169 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1987 | SUPPL-168 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/14/1987 | SUPPL-166 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/14/1987 | SUPPL-165 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/20/1987 | SUPPL-164 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/30/1982 | SUPPL-158 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/30/1982 | SUPPL-157 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/30/1982 | SUPPL-156 | Manufacturing (CMC) |
Label is not available on this site. |
HYDROCHLOROTHIAZIDE
TABLET;ORAL; 25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 202556 | ACCORD HLTHCARE |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040780 | AUROBINDO PHARMA |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 085182 | HERITAGE PHARMS |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040807 | IPCA LABS LTD |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 25MG | TABLET;ORAL | Prescription | Yes | AB | 083177 | IVAX SUB TEVA PHARMS |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040702 | LEADING |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 087059 | OXFORD PHARMS |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040412 | PRINSTON INC |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 203018 | SCIEGEN PHARMS INC |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 25MG | TABLET;ORAL | Prescription | No | AB | 040907 | UNICHEM |
TABLET;ORAL; 50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 202556 | ACCORD HLTHCARE |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040780 | AUROBINDO PHARMA |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 085182 | HERITAGE PHARMS |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040807 | IPCA LABS LTD |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | Yes | AB | 083177 | IVAX SUB TEVA PHARMS |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040702 | LEADING |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 087068 | OXFORD PHARMS |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040412 | PRINSTON INC |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 203018 | SCIEGEN PHARMS INC |
| HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 040907 | UNICHEM |