Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040298
Company: MYLAN

Products on ANDA 40298

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EXTENDED PHENYTOIN SODIUM	PHENYTOIN SODIUM	100MG EXTENDED	CAPSULE;ORAL	Discontinued	None	No	No
PHENYTEK	PHENYTOIN SODIUM	200MG EXTENDED	CAPSULE;ORAL	Prescription	AB	No	No
PHENYTEK	PHENYTOIN SODIUM	300MG EXTENDED	CAPSULE;ORAL	Prescription	AB	No	Yes

Labels for ANDA 040298

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/28/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/40298lbl.pdf