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Details for New Drug Application (NDA): 040298

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NDA 040298 describes PHENYTEK, which is a drug marketed by Mylan and is included in one NDA. It is available from ten suppliers. Additional details are available on the PHENYTEK profile page.

The generic ingredient in PHENYTEK 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: 040298

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
phenytoin sodium
CAPSULE;ORAL 040298 ANDA Mylan Pharmaceuticals Inc. 0378-1560 0378-1560-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1560-01)
phenytoin sodium
CAPSULE;ORAL 040298 ANDA Mylan Pharmaceuticals Inc. 0378-1560 0378-1560-10 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1560-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG EXTENDED
Approval Date:Dec 28, 1998TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG EXTENDED
Approval Date:Dec 6, 2001TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength300MG EXTENDED
Approval Date:Dec 6, 2001TE:ABRLD:Yes

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