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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040884
Company: EPIC PHARMA LLC

Products on ANDA 040884

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PHENYTOIN	PHENYTOIN	50MG	TABLET, CHEWABLE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040884

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.

Therapeutic Equivalents for ANDA 040884

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	Yes	AB	084427	PHARMACIA
PHENYTOIN	PHENYTOIN	50MG	TABLET, CHEWABLE;ORAL	Prescription	No	AB	040884	EPIC PHARMA LLC
PHENYTOIN	PHENYTOIN	50MG	TABLET, CHEWABLE;ORAL	Prescription	No	AB	200691	RISING
PHENYTOIN	PHENYTOIN	50MG	TABLET, CHEWABLE;ORAL	Prescription	No	AB	200565	TARO

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