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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 210189


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NDA 210189 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 210189
Tradename:PHYTONADIONE
Applicant:Zydus Lifesciences
Ingredient:phytonadione
Patents:0
Pharmacology for NDA: 210189
Suppliers and Packaging for NDA: 210189
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHYTONADIONE phytonadione TABLET;ORAL 210189 ANDA Northstar Rx LLC. 16714-973 16714-973-02 1 BOTTLE in 1 CARTON (16714-973-02) / 30 TABLET in 1 BOTTLE
PHYTONADIONE phytonadione TABLET;ORAL 210189 ANDA Zydus Pharmaceuticals USA Inc. 70710-1014 70710-1014-1 1 BOTTLE in 1 CARTON (70710-1014-1) / 100 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Feb 20, 2019TE:ABRLD:No

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