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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 Pfizer Pharms and Parke Davis and is included in four NDAs. It is available from eleven suppliers. Additional details are available on the DILANTIN profile page.

The generic ingredient in DILANTIN is phenytoin sodium. There are nineteen drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the phenytoin sodium profile page.

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG EXTENDED
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG EXTENDED
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes


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