Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074865
Company: WATSON LABS

Products on ANDA 074865

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	150MG	CAPSULE;ORAL	Discontinued	None	No	No
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	200MG	CAPSULE;ORAL	Discontinued	None	No	No
MEXILETINE HYDROCHLORIDE	MEXILETINE HYDROCHLORIDE	250MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074865

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/13/1998	ORIG-1	Approval			Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74865ap_appltr_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74865ap_appltr_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74865.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/27/2015	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 074865

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/13/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/74865ap_appltr_prntlbl.pdf