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FDA ANDA · ANDA074865

MEXILETINE HYDROCHLORIDE

Sponsor: WATSON LABS

APPLICATION
ANDA074865
TYPE
ANDA
ORIGINAL APPROVAL
1998-04-13
LATEST ACTION
2015-04-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

MEXILETINE HYDROCHLORIDEDiscontinued
MEXILETINE HYDROCHLORIDE 250MG · CAPSULE · ORAL
MEXILETINE HYDROCHLORIDEDiscontinued
MEXILETINE HYDROCHLORIDE 150MG · CAPSULE · ORAL
MEXILETINE HYDROCHLORIDEDiscontinued
MEXILETINE HYDROCHLORIDE 200MG · CAPSULE · ORAL

Approval history

2015-04-27Labeling · Supplement 2 · standardAP
1998-04-13Original — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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