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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203813
Company: MACLEODS PHARMS LTD

Products on ANDA 203813

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	4MG	TABLET;ORAL	Prescription	AB	No	No
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	8MG	TABLET;ORAL	Prescription	AB	No	No
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	16MG	TABLET;ORAL	Prescription	AB	No	No
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	32MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203813

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/05/2016	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
06/07/2023	SUPPL-27	Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Patient Package Insert		Label is not available on this site.
04/30/2021	SUPPL-16	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
07/19/2017	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 203813

CANDESARTAN CILEXETIL

TABLET;ORAL; 4MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATACAND	CANDESARTAN CILEXETIL	4MG	TABLET;ORAL	Prescription	Yes	AB	020838	ANI PHARMS
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	4MG	TABLET;ORAL	Prescription	No	AB	210302	ALEMBIC
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	4MG	TABLET;ORAL	Prescription	No	AB	203813	MACLEODS PHARMS LTD
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	4MG	TABLET;ORAL	Prescription	No	AB	078702	MYLAN
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	4MG	TABLET;ORAL	Prescription	No	AB	091390	ZYDUS LIFESCIENCES

TABLET;ORAL; 8MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATACAND	CANDESARTAN CILEXETIL	8MG	TABLET;ORAL	Prescription	Yes	AB	020838	ANI PHARMS
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	8MG	TABLET;ORAL	Prescription	No	AB	210302	ALEMBIC
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	8MG	TABLET;ORAL	Prescription	No	AB	203813	MACLEODS PHARMS LTD
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	8MG	TABLET;ORAL	Prescription	No	AB	078702	MYLAN
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	8MG	TABLET;ORAL	Prescription	No	AB	206233	PRINSTON INC
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	8MG	TABLET;ORAL	Prescription	No	AB	091390	ZYDUS LIFESCIENCES

TABLET;ORAL; 16MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATACAND	CANDESARTAN CILEXETIL	16MG	TABLET;ORAL	Prescription	Yes	AB	020838	ANI PHARMS
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	16MG	TABLET;ORAL	Prescription	No	AB	210302	ALEMBIC
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	16MG	TABLET;ORAL	Prescription	No	AB	203813	MACLEODS PHARMS LTD
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	16MG	TABLET;ORAL	Prescription	No	AB	078702	MYLAN
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	16MG	TABLET;ORAL	Prescription	No	AB	206233	PRINSTON INC
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	16MG	TABLET;ORAL	Prescription	No	AB	091390	ZYDUS LIFESCIENCES

TABLET;ORAL; 32MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATACAND	CANDESARTAN CILEXETIL	32MG	TABLET;ORAL	Prescription	Yes	AB	020838	ANI PHARMS
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	32MG	TABLET;ORAL	Prescription	No	AB	209119	ALEMBIC
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	32MG	TABLET;ORAL	Prescription	No	AB	203813	MACLEODS PHARMS LTD
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	32MG	TABLET;ORAL	Prescription	No	AB	078702	MYLAN
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	32MG	TABLET;ORAL	Prescription	No	AB	206233	PRINSTON INC
CANDESARTAN CILEXETIL	CANDESARTAN CILEXETIL	32MG	TABLET;ORAL	Prescription	No	AB	091390	ZYDUS LIFESCIENCES

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