Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040610
Company: VISTAPHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENYTOIN PHENYTOIN 125MG/5ML SUSPENSION;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
08/18/2005 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
01/16/2014 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

01/16/2014 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/16/2014 SUPPL-3 Labeling-Medication Guide

Label is not available on this site.

01/28/2010 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

PHENYTOIN

SUSPENSION;ORAL; 125MG/5ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DILANTIN-125 PHENYTOIN 125MG/5ML SUSPENSION;ORAL Prescription Yes AB 008762 PARKE DAVIS
PHENYTOIN PHENYTOIN 125MG/5ML SUSPENSION;ORAL Prescription No AB 040521 TARO
PHENYTOIN PHENYTOIN 125MG/5ML SUSPENSION;ORAL Prescription No AB 040342 VISTAPHARM
PHENYTOIN PHENYTOIN 125MG/5ML SUSPENSION;ORAL Prescription No AB 040610 VISTAPHARM
PHENYTOIN PHENYTOIN 125MG/5ML SUSPENSION;ORAL Prescription No AB 040420 WOCKHARDT BIO AG

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