Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215988
Company: I3 PHARMS

Products on ANDA 215988

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE	37.5MG;20MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215988

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/17/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/30/2024	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 215988

ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE

TABLET;ORAL; 37.5MG;20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BIDIL	HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE	37.5MG;20MG	TABLET;ORAL	Prescription	Yes	AB	020727	AZURITY
ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE	37.5MG;20MG	TABLET;ORAL	Prescription	No	AB	215988	I3 PHARMS
ISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDE	HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE	37.5MG;20MG	TABLET;ORAL	Prescription	No	AB	215586	RICONPHARMA LLC