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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 Intl Medication and Glaxosmithkline and is included in two NDAs. It is available from five suppliers. Additional details are available on the PHYTONADIONE profile page.

The generic ingredient in PHYTONADIONE is phytonadione. There are nine 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 NDA: 083722

Tradename:
PHYTONADIONE
Applicant:
Intl Medication
Ingredient:
phytonadione
Patents:0
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 Amphastar Pharmaceuticals, Inc. 0548-1140 0548-1140-00 25 SYRINGE in 1 CARTON (0548-1140-00) > .5 mL in 1 SYRINGE
PHYTONADIONE
phytonadione
INJECTABLE;INJECTION 083722 ANDA Amphastar Pharmaceuticals, Inc. 0548-1240 0548-1240-00 25 SYRINGE in 1 CARTON (0548-1240-00) > .5 mL in 1 SYRINGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/0.5ML
Approval Date:Approved Prior to Jan 1, 1982TE:BPRLD:Yes


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