Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204740
Company: AMNEAL PHARMS
Company: AMNEAL PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | AB | No | No |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | AB | No | No |
| IRBESARTAN | IRBESARTAN | 300MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/17/2018 | 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 |
|---|---|---|---|---|---|
| 02/23/2024 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/23/2024 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/23/2024 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/23/2019 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
IRBESARTAN
TABLET;ORAL; 75MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AVAPRO | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | Yes | AB | 020757 | SANOFI AVENTIS US |
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | No | AB | 091236 | ALEMBIC PHARMS LTD |
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | No | AB | 204740 | AMNEAL PHARMS |
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | No | AB | 203081 | AUROBINDO PHARMA LTD |
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | No | AB | 077205 | CHARTWELL MOLECULAR |
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | No | AB | 202910 | HETERO LABS LTD V |
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | No | AB | 206194 | HISUN PHARM HANGZHOU |
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | No | AB | 203534 | JUBILANT GENERICS |
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | No | AB | 201531 | LUPIN LTD |
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | No | AB | 202254 | MACLEODS PHARMS LTD |
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | No | AB | 203071 | PRINSTON INC |
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | No | AB | 077466 | SANDOZ |
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | No | AB | 204774 | SCIEGEN PHARMS INC |
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | No | AB | 077159 | TEVA PHARMS |
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | No | AB | 203020 | UNICHEM |
| IRBESARTAN | IRBESARTAN | 75MG | TABLET;ORAL | Prescription | No | AB | 079213 | ZYDUS PHARMS USA INC |
TABLET;ORAL; 150MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AVAPRO | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | Yes | AB | 020757 | SANOFI AVENTIS US |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | No | AB | 091236 | ALEMBIC PHARMS LTD |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | No | AB | 204740 | AMNEAL PHARMS |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | No | AB | 203081 | AUROBINDO PHARMA LTD |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | No | AB | 077205 | CHARTWELL MOLECULAR |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | No | AB | 202910 | HETERO LABS LTD V |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | No | AB | 206194 | HISUN PHARM HANGZHOU |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | No | AB | 203534 | JUBILANT GENERICS |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | No | AB | 201531 | LUPIN LTD |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | No | AB | 202254 | MACLEODS PHARMS LTD |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | No | AB | 203071 | PRINSTON INC |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | No | AB | 077466 | SANDOZ |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | No | AB | 204774 | SCIEGEN PHARMS INC |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | No | AB | 077159 | TEVA PHARMS |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | No | AB | 203020 | UNICHEM |
| IRBESARTAN | IRBESARTAN | 150MG | TABLET;ORAL | Prescription | No | AB | 079213 | ZYDUS PHARMS USA INC |
TABLET;ORAL; 300MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AVAPRO | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | Yes | AB | 020757 | SANOFI AVENTIS US |
| IRBESARTAN | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | No | AB | 091236 | ALEMBIC PHARMS LTD |
| IRBESARTAN | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | No | AB | 204740 | AMNEAL PHARMS |
| IRBESARTAN | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | No | AB | 203081 | AUROBINDO PHARMA LTD |
| IRBESARTAN | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | No | AB | 077205 | CHARTWELL MOLECULAR |
| IRBESARTAN | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | No | AB | 202910 | HETERO LABS LTD V |
| IRBESARTAN | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | No | AB | 206194 | HISUN PHARM HANGZHOU |
| IRBESARTAN | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | No | AB | 203534 | JUBILANT GENERICS |
| IRBESARTAN | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | No | AB | 201531 | LUPIN LTD |
| IRBESARTAN | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | No | AB | 202254 | MACLEODS PHARMS LTD |
| IRBESARTAN | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | No | AB | 203071 | PRINSTON INC |
| IRBESARTAN | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | No | AB | 077466 | SANDOZ |
| IRBESARTAN | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | No | AB | 204774 | SCIEGEN PHARMS INC |
| IRBESARTAN | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | No | AB | 077159 | TEVA PHARMS |
| IRBESARTAN | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | No | AB | 203020 | UNICHEM |
| IRBESARTAN | IRBESARTAN | 300MG | TABLET;ORAL | Prescription | No | AB | 079213 | ZYDUS PHARMS USA INC |