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Last Updated: April 25, 2024

Details for New Drug Application (NDA): 008762

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NDA 008762 describes DILANTIN-30, which is a drug marketed by Viatris and is included in one NDA. It is available from three suppliers. Additional details are available on the DILANTIN-30 profile page.

The generic ingredient in DILANTIN-30 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 008762
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 008762
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DILANTIN-125 phenytoin SUSPENSION;ORAL 008762 NDA Parke-Davis Div of Pfizer Inc 0071-2214 0071-2214-35 1 BOTTLE, PLASTIC in 1 CARTON (0071-2214-35) / 237 mL in 1 BOTTLE, PLASTIC
DILANTIN-125 phenytoin SUSPENSION;ORAL 008762 NDA Viatris Specialty LLC 58151-115 58151-115-35 1 BOTTLE, PLASTIC in 1 CARTON (58151-115-35) / 237 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength125MG/5ML
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:SUSPENSION;ORALStrength30MG/5ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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