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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219987
Company: MACLEODS PHARMS LTD

Products on ANDA 219987

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE;ORAL	Prescription	AB	No	No
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE;ORAL	Prescription	AB	No	No
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219987

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/23/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219987

MEXILETINE HYDROCHLORIDE

CAPSULE;ORAL; 150MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE;ORAL	Prescription	No	AB	074450	ANI PHARMS
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE;ORAL	Prescription	No	AB	216463	ANNORA PHARMA
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE;ORAL	Prescription	No	AB	213500	CROSSMEDIKA SA
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE;ORAL	Prescription	No	AB	214352	INGENUS PHARMS LLC
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE;ORAL	Prescription	No	AB	219987	MACLEODS PHARMS LTD
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE;ORAL	Prescription	No	AB	215876	QUAGEN
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE;ORAL	Prescription	No	AB	215315	RISING
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE;ORAL	Prescription	No	AB	214089	SENORES PHARMS
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE;ORAL	Prescription	No	AB	074377	TEVA

CAPSULE;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE;ORAL	Prescription	No	AB	074450	ANI PHARMS
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE;ORAL	Prescription	No	AB	216463	ANNORA PHARMA
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE;ORAL	Prescription	No	AB	213500	CROSSMEDIKA SA
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE;ORAL	Prescription	No	AB	214352	INGENUS PHARMS LLC
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE;ORAL	Prescription	No	AB	219987	MACLEODS PHARMS LTD
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE;ORAL	Prescription	No	AB	215876	QUAGEN
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE;ORAL	Prescription	No	AB	215315	RISING
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE;ORAL	Prescription	No	AB	214089	SENORES PHARMS
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE;ORAL	Prescription	No	AB	074377	TEVA

CAPSULE;ORAL; 250MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	074450	ANI PHARMS
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	216463	ANNORA PHARMA
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	213500	CROSSMEDIKA SA
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	214352	INGENUS PHARMS LLC
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	219987	MACLEODS PHARMS LTD
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	215876	QUAGEN
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	215315	RISING
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	214089	SENORES PHARMS
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Prescription	No	AB	074377	TEVA

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