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Generated: April 20, 2019

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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 five 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. Fourteen 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 Valeant Pharmaceuticals North America 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 Rebel Distributors Corp 21695-168 21695-168-10 10 TABLET in 1 BOTTLE (21695-168-10)

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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