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Serving hundreds of leading biopharmaceutical companies globally:

UBS
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Chinese Patent Office
AstraZeneca
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Generated: June 22, 2018

DrugPatentWatch Database Preview

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 ten suppliers. Additional details are available on the DILANTIN profile page.

The generic ingredient in DILANTIN is phenytoin. There are twenty drug master file entries for this compound. Fourteen 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
Therapeutic Class:Anticonvulsants
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 N 0071-0369-24
DILANTIN phenytoin sodium CAPSULE;ORAL 084349 ANDA Parke-Davis Div of Pfizer Inc 0071-0369 N 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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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Deloitte
McKinsey
Teva
UBS
Cerilliant
Colorcon
Medtronic
Federal Trade Commission

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