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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203020
Company: UNICHEM

Products on ANDA 203020

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203020

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/07/2015	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203020Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/20/2021	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
08/26/2021	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
04/23/2021	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 203020

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

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