Drugs@FDA: FDA-Approved Drugs

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

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 213500 CROSSMEDIKA SA
MEXILETINE HYDROCHLORIDE MEXILETINE HYDROCHLORIDE 150MG CAPSULE;ORAL Prescription No AB 214352 RICONPHARMA LLC
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 213500 CROSSMEDIKA SA
MEXILETINE HYDROCHLORIDE MEXILETINE HYDROCHLORIDE 200MG CAPSULE;ORAL Prescription No AB 214352 RICONPHARMA LLC
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 213500 CROSSMEDIKA SA
MEXILETINE HYDROCHLORIDE MEXILETINE HYDROCHLORIDE 250MG CAPSULE;ORAL Prescription No AB 214352 RICONPHARMA LLC
MEXILETINE HYDROCHLORIDE MEXILETINE HYDROCHLORIDE 250MG CAPSULE;ORAL Prescription No AB 074377 TEVA

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