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Last Updated: April 18, 2021

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PHYTONADIONE - Generic Drug Details

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What are the generic drug sources for phytonadione and what is the scope of freedom to operate?

Phytonadione is the generic ingredient in five branded drugs marketed by Teligent, Roche, Dr Reddys Labs Ltd, Glaxosmithkline, Intl Medication, Hospira, Bausch, Amneal Pharms Co, and Zydus, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for phytonadione. Fourteen suppliers are listed for this compound.

Summary for PHYTONADIONE
Drug Prices for PHYTONADIONE

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Recent Clinical Trials for PHYTONADIONE

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SponsorPhase
Wayne State UniversityEarly Phase 1
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

See all PHYTONADIONE clinical trials

US Patents and Regulatory Information for PHYTONADIONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche KONAKION phytonadione INJECTABLE;INJECTION 011745-003 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Hospira VITAMIN K1 phytonadione INJECTABLE;INJECTION 087954-001 Jul 25, 1983 BP RX No Yes   Start Trial   Start Trial   Start Trial
Glaxosmithkline PHYTONADIONE phytonadione INJECTABLE;INJECTION 084060-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Intl Medication PHYTONADIONE phytonadione INJECTABLE;INJECTION 083722-001 Approved Prior to Jan 1, 1982 BP RX No Yes   Start Trial   Start Trial   Start Trial
Teligent AQUAMEPHYTON phytonadione INJECTABLE;INJECTION 012223-001 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Roche KONAKION phytonadione INJECTABLE;INJECTION 011745-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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