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Boehringer Ingelheim

Last Updated: December 2, 2023

Details for New Drug Application (NDA): 084427

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NDA 084427 describes DILANTIN, which is a drug marketed by Viatris, Parke Davis, and Pharmacia, and is included in four NDAs. It is available from five suppliers. Additional details are available on the DILANTIN profile page.

The generic ingredient in DILANTIN is phenytoin. There are twenty-one drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the phenytoin profile page.
Summary for 084427
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 084427
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DILANTIN phenytoin TABLET, CHEWABLE;ORAL 084427 ANDA Parke-Davis Div of Pfizer Inc 0071-0007 0071-0007-24 100 TABLET, CHEWABLE in 1 BOTTLE (0071-0007-24)
DILANTIN phenytoin TABLET, CHEWABLE;ORAL 084427 ANDA Parke-Davis Div of Pfizer Inc 0071-0007 0071-0007-40 100 BLISTER PACK in 1 BOX, UNIT-DOSE (0071-0007-40) / 1 TABLET, CHEWABLE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength50MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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