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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 219212


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NDA 219212 describes PHYTONADIONE, which is a drug marketed by Alembic, Amneal, Caplin, Cipla, Dr Reddys, Gland, Glaxosmithkline, Intl Medication, Agnitio, Amneal Pharms Co, Hikma, Sciegen Pharms Inc, and Zydus Lifesciences, and is included in fifteen NDAs. It is available from twenty-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. Twenty-six suppliers are listed for this compound. Additional details are available on the phytonadione profile page.
Summary for 219212
Tradename:PHYTONADIONE
Applicant:Caplin
Ingredient:phytonadione
Patents:0
Pharmacology for NDA: 219212
Physiological EffectIncreased Prothrombin Activity
Reversed Anticoagulation Activity
Suppliers and Packaging for NDA: 219212
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHYTONADIONE phytonadione INJECTABLE;INJECTION 219212 ANDA Caplin Steriles Limited 65145-151 65145-151-10 2 TRAY in 1 CARTON (65145-151-10) / 5 VIAL, SINGLE-DOSE in 1 TRAY (65145-151-05) / 1 mL in 1 VIAL, SINGLE-DOSE (65145-151-01)
PHYTONADIONE phytonadione INJECTABLE;INJECTION 219212 ANDA Fresenius Kabi USA, LLC 65219-635 65219-635-01 2 TRAY in 1 CARTON (65219-635-01) / 5 VIAL, SINGLE-DOSE in 1 TRAY (65219-635-00) / 1 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Apr 17, 2025TE:AB1RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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