Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040858
Company: HERITAGE PHARMS INC

Products on ANDA 040858

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	AA	No	No
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	AA	No	No
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	AA	No	No
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040858

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/26/2010	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-2	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 040858

HYDRALAZINE HYDROCHLORIDE

TABLET;ORAL; 10MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AA	200737	ALKEM LABS LTD
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AA	090527	GLENMARK PHARMS LTD
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AA	086242	HERITAGE PHARMS
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AA	040858	HERITAGE PHARMS INC
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AA	040901	HETERO LABS LTD III
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AA	089097	PLIVA
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AA	205236	SCIEGEN PHARMS INC
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AA	087836	STRIDES PHARMA

TABLET;ORAL; 25MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AA	200737	ALKEM LABS LTD
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AA	203845	CADILA PHARMS LTD
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AA	090527	GLENMARK PHARMS LTD
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AA	086242	HERITAGE PHARMS
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AA	040858	HERITAGE PHARMS INC
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AA	040901	HETERO LABS LTD III
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	Yes	AA	088467	PLIVA
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AA	205236	SCIEGEN PHARMS INC
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AA	086961	STRIDES PHARMA
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Prescription	No	AA	200770	STRIDES PHARMA

TABLET;ORAL; 50MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AA	200737	ALKEM LABS LTD
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AA	203845	CADILA PHARMS LTD
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AA	090527	GLENMARK PHARMS LTD
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AA	086242	HERITAGE PHARMS
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AA	040858	HERITAGE PHARMS INC
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AA	040901	HETERO LABS LTD III
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	Yes	AA	088468	PLIVA
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AA	205236	SCIEGEN PHARMS INC
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AA	086962	STRIDES PHARMA
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Prescription	No	AA	200770	STRIDES PHARMA

TABLET;ORAL; 100MG
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AA	200737	ALKEM LABS LTD
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AA	203845	CADILA PHARMS LTD
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AA	090527	GLENMARK PHARMS LTD
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AA	086242	HERITAGE PHARMS
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AA	040858	HERITAGE PHARMS INC
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AA	040901	HETERO LABS LTD III
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AA	089098	PLIVA
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AA	205236	SCIEGEN PHARMS INC
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AA	088391	STRIDES PHARMA
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET;ORAL	Prescription	No	AA	200770	STRIDES PHARMA