An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074450
Company: ANI PHARMS

Products on ANDA 074450

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 074450

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/16/1996	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
04/29/2015	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
04/19/2002	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
11/06/2001	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
11/30/2000	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
09/18/2000	SUPPL-10	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
03/16/2000	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
09/07/1999	SUPPL-8	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
09/07/1999	SUPPL-7	Labeling		Label is not available on this site.
05/07/1999	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
09/07/1999	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
05/07/1999	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
06/22/1998	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
08/20/1996	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 074450

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

Top