An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 040807
Company: IPCA LABS LTD

Products on ANDA 040807

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040807

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/20/2007	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
08/20/2020	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
10/13/2011	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
10/19/2009	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 040807

HYDROCHLOROTHIAZIDE

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 PHARMS
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	12.5MG	TABLET;ORAL	Prescription	No	AB	040807	IPCA LABS LTD
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	12.5MG	TABLET;ORAL	Prescription	No	AB	040702	LEADING

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 PHARMS
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	25MG	TABLET;ORAL	Prescription	No	AB	040807	IPCA LABS LTD
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	040412	PRINSTON INC
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	25MG	TABLET;ORAL	Prescription	No	AB	203018	SCIEGEN PHARMS INC
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 PHARMS
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	50MG	TABLET;ORAL	Prescription	No	AB	040807	IPCA LABS LTD
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	040412	PRINSTON INC
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	50MG	TABLET;ORAL	Prescription	No	AB	203018	SCIEGEN PHARMS INC
HYDROCHLOROTHIAZIDE	HYDROCHLOROTHIAZIDE	50MG	TABLET;ORAL	Prescription	No	AB	040907	UNICHEM

Top