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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 209373


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NDA 209373 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 209373
Tradename:PHYTONADIONE
Applicant:Amneal Pharms Co
Ingredient:phytonadione
Patents:0
Pharmacology for NDA: 209373
Suppliers and Packaging for NDA: 209373
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHYTONADIONE phytonadione TABLET;ORAL 209373 ANDA Major Pharmaceuticals 0904-6882 0904-6882-10 20 BLISTER PACK in 1 CARTON (0904-6882-10) / 1 TABLET in 1 BLISTER PACK
PHYTONADIONE phytonadione TABLET;ORAL 209373 ANDA AvKARE 42291-566 42291-566-30 1 BOTTLE in 1 BOX (42291-566-30) / 30 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:May 11, 2018TE:ABRLD:No

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