Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040430
Company: BIONPHARMA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ETHOSUXIMIDE ETHOSUXIMIDE 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
10/28/2002 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
01/07/2014 SUPPL-8 Labeling-Medication Guide

Label is not available on this site.

10/19/2012 SUPPL-7 REMS-Modified

Label is not available on this site.

12/27/2011 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

12/10/2009 SUPPL-5 Labeling

Label is not available on this site.

03/03/2008 SUPPL-4 Labeling

Label is not available on this site.

ETHOSUXIMIDE

CAPSULE;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ETHOSUXIMIDE ETHOSUXIMIDE 250MG CAPSULE;ORAL Prescription No AB 040686 AKORN
ETHOSUXIMIDE ETHOSUXIMIDE 250MG CAPSULE;ORAL Prescription No AB 040430 BIONPHARMA INC
ETHOSUXIMIDE ETHOSUXIMIDE 250MG CAPSULE;ORAL Prescription No AB 200892 HERITAGE PHARMS INC
ETHOSUXIMIDE ETHOSUXIMIDE 250MG CAPSULE;ORAL Prescription No AB 211928 STRIDES PHARMA
ZARONTIN ETHOSUXIMIDE 250MG CAPSULE;ORAL Prescription Yes AB 012380 PARKE DAVIS

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