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DILANTIN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: VIATRIS · Approved 1976-08-27

Drug application

FDA Application #
ANDA084349
Application type
Abbreviated New Drug Application (Generic)
Brand name
DILANTIN
Generic name
EXTENDED PHENYTOIN SODIUM
Active ingredients
PHENYTOIN SODIUM
Dosage form
CAPSULE
Route
ORAL
Marketing status
Prescription
Sponsor
VIATRIS
Manufacturer
Viatris Specialty LLC
First approval
1976-08-27

Source

Authoritative
Drugs@FDA application overview
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