Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202910
Company: HETERO LABS LTD V
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
08/09/2016 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

08/09/2016 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

11/06/2015 SUPPL-1 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 203161 NEOPHARMA
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 LABS LTD
IRBESARTAN IRBESARTAN 75MG TABLET;ORAL Prescription No AB 090201 WEST-WARD PHARMS INT
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 203161 NEOPHARMA
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 LABS LTD
IRBESARTAN IRBESARTAN 150MG TABLET;ORAL Prescription No AB 090201 WEST-WARD PHARMS INT
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 203161 NEOPHARMA
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 LABS LTD
IRBESARTAN IRBESARTAN 300MG TABLET;ORAL Prescription No AB 090201 WEST-WARD PHARMS INT
IRBESARTAN IRBESARTAN 300MG TABLET;ORAL Prescription No AB 079213 ZYDUS PHARMS USA INC

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