Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040884
Company: EPIC PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENYTOIN PHENYTOIN 50MG TABLET, CHEWABLE;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
11/28/2014 ORIG-1 Approval

Label is not available on this site.

PHENYTOIN

TABLET, CHEWABLE;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DILANTIN PHENYTOIN 50MG TABLET, CHEWABLE;ORAL Prescription No AB 084427 PFIZER
PHENYTOIN PHENYTOIN 50MG TABLET, CHEWABLE;ORAL Prescription No AB 040884 EPIC PHARMA LLC
PHENYTOIN PHENYTOIN 50MG TABLET, CHEWABLE;ORAL Prescription No AB 200691 MYLAN PHARMS INC
PHENYTOIN PHENYTOIN 50MG TABLET, CHEWABLE;ORAL Prescription No AB 200565 TARO

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