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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 083722


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NDA 083722 describes PHYTONADIONE, which is a drug marketed by Cipla, Dr Reddys, Glaxosmithkline, Intl Medication, Agnitio, Amneal Pharms Co, Sciegen Pharms Inc, and Zydus Lifesciences, and is included in nine NDAs. It is available from fifteen 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. Seventeen suppliers are listed for this compound. Additional details are available on the phytonadione profile page.
Summary for 083722
Tradename:PHYTONADIONE
Applicant:Intl Medication
Ingredient:phytonadione
Patents:0
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 Henry Schein, Inc. 0404-9935 0404-9935-05 1 BOX in 1 BAG (0404-9935-05) / 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:Yes

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