Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 086242
Company: HERITAGE

Products on ANDA 086242

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	10MG	TABLET;ORAL	Discontinued	None	No	No
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	50MG	TABLET;ORAL	Discontinued	None	No	No
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	25MG	TABLET;ORAL	Discontinued	None	No	No
HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE	100MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 086242

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/23/1978	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
04/21/2025	SUPPL-51	Labeling-Package Insert		Label is not available on this site.
04/21/2025	SUPPL-44	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
02/04/2010	SUPPL-29	Labeling		Label is not available on this site.
03/04/1999	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
12/07/1998	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
01/31/1996	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
09/12/1989	SUPPL-14	Labeling		Label is not available on this site.
10/02/1987	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
06/17/1983	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
09/10/1982	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
06/18/1982	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
06/18/1982	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.