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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074377
Company: TEVA
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 Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/16/1995 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
04/27/2015 SUPPL-16 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

12/06/2001 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/2001 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

03/09/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/17/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/24/1997 SUPPL-2 Labeling

Label is not available on this site.

10/11/1996 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 216463 ANNORA PHARMA
MEXILETINE HYDROCHLORIDE MEXILETINE HYDROCHLORIDE 150MG CAPSULE;ORAL Prescription No AB 215315 AUCTA
MEXILETINE HYDROCHLORIDE MEXILETINE HYDROCHLORIDE 150MG CAPSULE;ORAL Prescription No AB 213500 CROSSMEDIKA SA
MEXILETINE HYDROCHLORIDE MEXILETINE HYDROCHLORIDE 150MG CAPSULE;ORAL Prescription No AB 214352 NOVAST LABS
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 215315 AUCTA
MEXILETINE HYDROCHLORIDE MEXILETINE HYDROCHLORIDE 200MG CAPSULE;ORAL Prescription No AB 213500 CROSSMEDIKA SA
MEXILETINE HYDROCHLORIDE MEXILETINE HYDROCHLORIDE 200MG CAPSULE;ORAL Prescription No AB 214352 NOVAST LABS
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 215315 AUCTA
MEXILETINE HYDROCHLORIDE MEXILETINE HYDROCHLORIDE 250MG CAPSULE;ORAL Prescription No AB 213500 CROSSMEDIKA SA
MEXILETINE HYDROCHLORIDE MEXILETINE HYDROCHLORIDE 250MG CAPSULE;ORAL Prescription No AB 214352 NOVAST LABS
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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