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Generated: November 14, 2018

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Details for New Drug Application (NDA): 008762

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NDA 008762 describes DILANTIN-30, which is a drug marketed by Parke Davis and is included in one NDA. It is available from two 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. Thirteen suppliers are listed for this compound. Additional details are available on the phenytoin profile page.
Summary for 008762
Applicant:Parke Davis
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 0071-2214-20 237 mL in 1 BOTTLE (0071-2214-20)
DILANTIN-125 phenytoin SUSPENSION;ORAL 008762 NDA AUTHORIZED GENERIC Greenstone LLC 59762-0531 59762-0531-1 237 mL in 1 BOTTLE (59762-0531-1)

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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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
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