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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091370
Company: ALEMBIC

Products on ANDA 091370

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 AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN	25MG;300MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091370

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/12/2016	ORIG-2	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/091370Orig1s000ltr.pdf
10/15/2012	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
01/14/2026	SUPPL-38	Labeling-Package Insert		Label is not available on this site.
08/25/2023	SUPPL-30	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
08/25/2023	SUPPL-28	Labeling-Package Insert		Label is not available on this site.
06/04/2021	SUPPL-26	Labeling-Package Insert		Label is not available on this site.
06/04/2021	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
04/25/2019	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
04/25/2019	SUPPL-8	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
08/29/2013	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091370

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

TABLET;ORAL; 25MG;300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN	25MG;300MG	TABLET;ORAL	Prescription	No	AB	091370	ALEMBIC
IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN	25MG;300MG	TABLET;ORAL	Prescription	No	AB	203630	AUROBINDO PHARMA LTD
IRBESARTAN AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; IRBESARTAN	25MG;300MG	TABLET;ORAL	Prescription	No	AB	090351	HIKMA

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