Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214352
Company: RICONPHARMA LLC
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
01/25/2021 ORIG-1 Approval STANDARD

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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