Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203081
Company: AUROBINDO PHARMA LTD
Company: AUROBINDO PHARMA LTD
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 |
---|---|---|---|---|---|---|---|
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 |
---|---|---|---|---|---|
12/20/2021 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
09/01/2021 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
05/06/2021 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
12/13/2018 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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08/09/2016 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
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09/15/2014 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
09/22/2014 | SUPPL-4 | Labeling-Container/Carton Labels |
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 |
---|---|---|---|---|---|---|---|---|
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 | 211056 | IPCA LABS LTD |
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 | 211056 | IPCA LABS LTD |
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 | 211056 | IPCA LABS LTD |
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 |