Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040702
Company: LEADING

Products on ANDA 040702

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	25MG	TABLET;ORAL	Prescription	AB	No	No
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	50MG	TABLET;ORAL	Prescription	AB	No	No
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	12.5MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040702

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/16/2007	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
10/06/2023	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
08/20/2020	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
10/22/2014	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
05/01/2008	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 040702

HYDROCHLOROTHIAZIDE

TABLET;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	25MG	TABLET;ORAL	Prescription	No	AB	202556	ACCORD HLTHCARE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	25MG	TABLET;ORAL	Prescription	No	AB	040780	AUROBINDO PHARMA
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	25MG	TABLET;ORAL	Prescription	No	AB	085182	HERITAGE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	25MG	TABLET;ORAL	Prescription	Yes	AB	083177	IVAX SUB TEVA PHARMS
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	25MG	TABLET;ORAL	Prescription	No	AB	040702	LEADING
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	25MG	TABLET;ORAL	Prescription	No	AB	087059	OXFORD PHARMS
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	25MG	TABLET;ORAL	Prescription	No	AB	203018	SCIEGEN PHARMS
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	25MG	TABLET;ORAL	Prescription	No	AB	040907	UNICHEM

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	50MG	TABLET;ORAL	Prescription	No	AB	202556	ACCORD HLTHCARE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	50MG	TABLET;ORAL	Prescription	No	AB	040780	AUROBINDO PHARMA
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	50MG	TABLET;ORAL	Prescription	No	AB	085182	HERITAGE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	50MG	TABLET;ORAL	Prescription	Yes	AB	083177	IVAX SUB TEVA PHARMS
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	50MG	TABLET;ORAL	Prescription	No	AB	040702	LEADING
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	50MG	TABLET;ORAL	Prescription	No	AB	087068	OXFORD PHARMS
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	50MG	TABLET;ORAL	Prescription	No	AB	203018	SCIEGEN PHARMS
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	50MG	TABLET;ORAL	Prescription	No	AB	040907	UNICHEM

TABLET;ORAL; 12.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	12.5MG	TABLET;ORAL	Prescription	No	AB	202556	ACCORD HLTHCARE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	12.5MG	TABLET;ORAL	Prescription	No	AB	040707	ACTAVIS ELIZABETH
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	12.5MG	TABLET;ORAL	Prescription	No	AB	085182	HERITAGE
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	12.5MG	TABLET;ORAL	Prescription	Yes	AB	083177	IVAX SUB TEVA PHARMS
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	12.5MG	TABLET;ORAL	Prescription	No	AB	040702	LEADING
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	12.5MG	TABLET;ORAL	Prescription	No	AB	040907	UNICHEM