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Last Updated: August 11, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209373

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NDA 209373 describes PHYTONADIONE, which is a drug marketed by Dr Reddys Labs Ltd, Glaxosmithkline, Intl Medication, Amneal Pharms Co, and Zydus, and is included in five NDAs. It is available from nine 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. Thirteen 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
Formulation / Manufacturing:see details
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 American Health Packaging 60687-381 60687-381-94 20 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-381-94) > 1 TABLET in 1 BLISTER PACK (60687-381-11)

Profile for product number 001

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

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