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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203018
Company: SCIEGEN PHARMS INC

Products on ANDA 203018

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203018

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/23/2014	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-7	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203018

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 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

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