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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204801
Company: MACLEODS PHARMS LTD

Products on ANDA 204801

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;20MG	TABLET;ORAL	Prescription	AB	No	No
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;40MG	TABLET;ORAL	Prescription	AB	No	No
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	25MG;40MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204801

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/01/2023	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 204801

OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE

TABLET;ORAL; 12.5MG;20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENICAR HCT	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;20MG	TABLET;ORAL	Prescription	Yes	AB	021532	COSETTE
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;20MG	TABLET;ORAL	Prescription	No	AB	209281	ACCORD HLTHCARE
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;20MG	TABLET;ORAL	Prescription	No	AB	204233	ALEMBIC
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;20MG	TABLET;ORAL	Prescription	No	AB	205391	AUROBINDO PHARMA
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;20MG	TABLET;ORAL	Prescription	No	AB	204801	MACLEODS PHARMS LTD
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;20MG	TABLET;ORAL	Prescription	No	AB	207804	PRINSTON INC
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;20MG	TABLET;ORAL	Prescription	No	AB	208847	UMEDICA

TABLET;ORAL; 12.5MG;40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENICAR HCT	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;40MG	TABLET;ORAL	Prescription	Yes	AB	021532	COSETTE
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;40MG	TABLET;ORAL	Prescription	No	AB	209281	ACCORD HLTHCARE
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;40MG	TABLET;ORAL	Prescription	No	AB	204233	ALEMBIC
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;40MG	TABLET;ORAL	Prescription	No	AB	205391	AUROBINDO PHARMA
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;40MG	TABLET;ORAL	Prescription	No	AB	204801	MACLEODS PHARMS LTD
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;40MG	TABLET;ORAL	Prescription	No	AB	207804	PRINSTON INC
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;40MG	TABLET;ORAL	Prescription	No	AB	200532	TEVA PHARMS USA
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;40MG	TABLET;ORAL	Prescription	No	AB	208847	UMEDICA

TABLET;ORAL; 25MG;40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENICAR HCT	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	25MG;40MG	TABLET;ORAL	Prescription	Yes	AB	021532	COSETTE
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	25MG;40MG	TABLET;ORAL	Prescription	No	AB	209281	ACCORD HLTHCARE
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	25MG;40MG	TABLET;ORAL	Prescription	No	AB	204233	ALEMBIC
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	25MG;40MG	TABLET;ORAL	Prescription	No	AB	205391	AUROBINDO PHARMA
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	25MG;40MG	TABLET;ORAL	Prescription	No	AB	204801	MACLEODS PHARMS LTD
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	25MG;40MG	TABLET;ORAL	Prescription	No	AB	207804	PRINSTON INC
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	25MG;40MG	TABLET;ORAL	Prescription	No	AB	208847	UMEDICA

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