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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 087955


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NDA 087955 describes VITAMIN K1, which is a drug marketed by Hospira and is included in three NDAs. It is available from two suppliers. Additional details are available on the VITAMIN K1 profile page.

The generic ingredient in VITAMIN K1 is phytonadione. There are ten drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the phytonadione profile page.
Summary for 087955
Tradename:VITAMIN K1
Applicant:Hospira
Ingredient:phytonadione
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 087955
Suppliers and Packaging for NDA: 087955
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VITAMIN K1 phytonadione INJECTABLE;INJECTION 087955 ANDA Hospira, Inc. 0409-9158 0409-9158-01 5 TRAY in 1 CONTAINER (0409-9158-01) > 5 AMPULE in 1 TRAY (0409-9158-50) > 1 mL in 1 AMPULE (0409-9158-31)
VITAMIN K1 phytonadione INJECTABLE;INJECTION 087955 ANDA A-S Medication Solutions 50090-4521 50090-4521-0 1 mL in 1 AMPULE (50090-4521-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Jul 25, 1983TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Medtronic
Dow
Johnson and Johnson
Moodys
Boehringer Ingelheim
Baxter

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