Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202414
Company: MACLEODS PHARMS LTD
Company: MACLEODS PHARMS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;150MG | TABLET;ORAL | Prescription | AB | No | No |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;300MG | TABLET;ORAL | Prescription | AB | No | No |
| IRBESARTAN; HYDROCHLOROTHIAZIDE | IRBESARTAN: HYDROCHLOROTHIAZIDE | 300MG; 25MG | TABLET; ORAL | None (Tentative Approval) | None | 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 |
|---|---|---|---|---|---|---|---|
| 09/27/2012 | ORIG-2 | Tentative Approval |
Label is not available on this site. |
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| 09/27/2012 | 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 |
|---|---|---|---|---|---|
| 11/25/2025 | SUPPL-72 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/05/2022 | SUPPL-49 | Labeling-Package Insert |
Label is not available on this site. |
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| 04/05/2022 | SUPPL-47 | Labeling-Package Insert |
Label is not available on this site. |
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| 06/04/2021 | SUPPL-43 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/04/2021 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/02/2019 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/02/2019 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/22/2016 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/18/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/05/2012 | SUPPL-3 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
IRBESARTAN AND HYDROCHLOROTHIAZIDE
TABLET;ORAL; 12.5MG;150MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AVALIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;150MG | TABLET;ORAL | Prescription | Yes | AB | 020758 | SANOFI AVENTIS US |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;150MG | TABLET;ORAL | Prescription | No | AB | 091370 | ALEMBIC |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;150MG | TABLET;ORAL | Prescription | No | AB | 203630 | AUROBINDO PHARMA LTD |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;150MG | TABLET;ORAL | Prescription | No | AB | 203500 | DR REDDYS LABS LTD |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;150MG | TABLET;ORAL | Prescription | No | AB | 090351 | HIKMA |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;150MG | TABLET;ORAL | Prescription | No | AB | 207896 | HISUN PHARM HANGZHOU |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;150MG | TABLET;ORAL | Prescription | No | AB | 202414 | MACLEODS PHARMS LTD |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;150MG | TABLET;ORAL | Prescription | No | AB | 203072 | PRINSTON INC |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;150MG | TABLET;ORAL | Prescription | No | AB | 077446 | SANDOZ |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;150MG | TABLET;ORAL | Prescription | No | AB | 077369 | TEVA |
TABLET;ORAL; 12.5MG;300MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AVALIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;300MG | TABLET;ORAL | Prescription | Yes | AB | 020758 | SANOFI AVENTIS US |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;300MG | TABLET;ORAL | Prescription | No | AB | 091370 | ALEMBIC |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;300MG | TABLET;ORAL | Prescription | No | AB | 203630 | AUROBINDO PHARMA LTD |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;300MG | TABLET;ORAL | Prescription | No | AB | 203500 | DR REDDYS LABS LTD |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;300MG | TABLET;ORAL | Prescription | No | AB | 090351 | HIKMA |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;300MG | TABLET;ORAL | Prescription | No | AB | 207896 | HISUN PHARM HANGZHOU |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;300MG | TABLET;ORAL | Prescription | No | AB | 202414 | MACLEODS PHARMS LTD |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;300MG | TABLET;ORAL | Prescription | No | AB | 203072 | PRINSTON INC |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;300MG | TABLET;ORAL | Prescription | No | AB | 077446 | SANDOZ |
| IRBESARTAN AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDE; IRBESARTAN | 12.5MG;300MG | TABLET;ORAL | Prescription | No | AB | 077369 | TEVA |
IRBESARTAN; HYDROCHLOROTHIAZIDE
There are no Therapeutic Equivalents.