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Generated: November 18, 2018

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Details for New Drug Application (NDA): 084349

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NDA 084349 describes DILANTIN, which is a drug marketed by Parke-davis, Parke Davis, and Pfizer, and is included in four NDAs. It is available from nine 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. Thirteen suppliers are listed for this compound. Additional details are available on the phenytoin profile page.
Summary for 084349
Tradename:DILANTIN
Applicant:Parke-davis
Ingredient:phenytoin sodium
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 084349
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DILANTIN phenytoin sodium CAPSULE;ORAL 084349 ANDA Parke-Davis Div of Pfizer Inc 0071-0369 0071-0369-24 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0071-0369-24)
DILANTIN phenytoin sodium CAPSULE;ORAL 084349 ANDA Parke-Davis Div of Pfizer Inc 0071-0369 0071-0369-32 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0071-0369-32)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG EXTENDED
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG EXTENDED
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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