Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040707
Company: ACTAVIS ELIZABETH

Products on ANDA 040707

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040707

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/27/2007	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-17	Labeling-Package Insert		Label is not available on this site.
09/16/2007	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.

Therapeutic Equivalents for ANDA 040707

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
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