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Generated: October 22, 2018

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Details for New Drug Application (NDA): 083722

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NDA 083722 describes PHYTONADIONE, which is a drug marketed by Glaxosmithkline, Intl Medication, and Amneal Pharms Co, and is included in three NDAs. It is available from four suppliers. Additional details are available on the PHYTONADIONE profile page.

The generic ingredient in PHYTONADIONE is phytonadione. There are ten drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the phytonadione profile page.
Summary for 083722
Applicant:Intl Medication
Formulation / Manufacturing:see details
Pharmacology for NDA: 083722
Suppliers and Packaging for NDA: 083722
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHYTONADIONE phytonadione INJECTABLE;INJECTION 083722 ANDA General Injectables & Vaccines, Inc 52584-046 52584-046-01 1 BOX in 1 BAG (52584-046-01) > 1 SYRINGE in 1 BOX > .5 mL in 1 SYRINGE
PHYTONADIONE phytonadione INJECTABLE;INJECTION 083722 ANDA International Medication Systems, Limited 76329-1240 76329-1240-1 1 SYRINGE in 1 CARTON (76329-1240-1) > .5 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/0.5ML
Approval Date:Approved Prior to Jan 1, 1982TE:BPRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
US Army
Fish and Richardson
Johnson and Johnson

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