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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218613
Company: REGCON HOLDINGS

Products on ANDA 218613

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOFEXIDINE HYDROCHLORIDE	LOFEXIDINE HYDROCHLORIDE	EQ 0.18MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218613

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/20/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218613

LOFEXIDINE HYDROCHLORIDE

TABLET;ORAL; EQ 0.18MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LOFEXIDINE HYDROCHLORIDE	LOFEXIDINE HYDROCHLORIDE	EQ 0.18MG BASE	TABLET;ORAL	Prescription	No	AB	218699	MSN
LOFEXIDINE HYDROCHLORIDE	LOFEXIDINE HYDROCHLORIDE	EQ 0.18MG BASE	TABLET;ORAL	Prescription	No	AB	219917	NOVITIUM PHARMA
LOFEXIDINE HYDROCHLORIDE	LOFEXIDINE HYDROCHLORIDE	EQ 0.18MG BASE	TABLET;ORAL	Prescription	No	AB	218613	REGCON HOLDINGS
LUCEMYRA	LOFEXIDINE HYDROCHLORIDE	EQ 0.18MG BASE	TABLET;ORAL	Prescription	Yes	AB	209229	BIOCORRX PHARMS

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