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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 213336


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NDA 213336 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 213336
Tradename:PHYTONADIONE
Applicant:Agnitio
Ingredient:phytonadione
Patents:0
Pharmacology for NDA: 213336
Suppliers and Packaging for NDA: 213336
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHYTONADIONE phytonadione TABLET;ORAL 213336 ANDA Agnitio Inc. 72134-008 72134-008-01 100 TABLET in 1 BOTTLE (72134-008-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Oct 12, 2023TE:ABRLD:No

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