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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200892
Company: HERITAGE PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ETHOSUXIMIDE ETHOSUXIMIDE 250MG CAPSULE;ORAL Discontinued None 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
09/25/2012 ORIG-1 Approval Not Applicable

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/22/2022 SUPPL-14 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

03/16/2020 SUPPL-2 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

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