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Last Updated: May 20, 2022

Details for New Drug Application (NDA): 010104

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NDA 010104 describes MEPHYTON, which is a drug marketed by Bausch and is included in one NDA. It is available from four suppliers. Additional details are available on the MEPHYTON profile page.

The generic ingredient in MEPHYTON is phytonadione. There are ten drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the phytonadione profile page.
Summary for 010104
Formulation / Manufacturing:see details
Pharmacology for NDA: 010104
Suppliers and Packaging for NDA: 010104
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MEPHYTON phytonadione TABLET;ORAL 010104 NDA Bausch Health US LLC 0187-1704 0187-1704-05 1 BOTTLE in 1 CARTON (0187-1704-05) > 100 TABLET in 1 BOTTLE
MEPHYTON phytonadione TABLET;ORAL 010104 NDA A-S Medication Solutions 50090-1753 50090-1753-0 5 TABLET in 1 BOTTLE (50090-1753-0)

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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