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Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.

PHYTONADIONE

ANDANot in Orange Book

PHYTONADIONE | A219175 | LUPIN

API Supply Chain11 active DMFs1 inactive

9 active API suppliers hold Drug Master Files for this ingredient.

BIOPHORE INDIA PHARMACEUTICALS PVT LTDPHYTONADIONE

DMF 264472012

G AND A ASSOC INCPHYTONADIONE USP, NON STERILE, BULK DRUG

DMF 266542012

BIOPHORE INDIA PHARMACEUTICALS PVT LTDPHYTONADIONE ROUTE-B

DMF 278052013

MSN LABORATORIES PRIVATE LTDPHYTONADIONE USP [ROUTE CODE "HN"]

DMF 296692015

ENALTEC LABS PRIVATE LTDPHYTONADIONE USP

DMF 301762016

EMCURE PHARMACEUTICALS LTDPHYTONADIONE USP

DMF 307752016

NAVINTA LLCPHYTONADIONE USP (PROCESS A)

DMF 309102016

ENALTEC LABS PRIVATE LTDPHYTONADIONE USP

DMF 329472018

SUNNY PHARMTECH INCPHYTONADIONE, USP

DMF 340542019

AMPHASTAR NANJING PHARMACEUTICALS INCPHYTONADIONE USP

DMF 379532023

ANHUI WANHE PHARMACEUTICAL CO LTDPHYTONADIONE (VITAMIN K1)

DMF 428962025

NISSHIN PHARMA INCInactivePHYTONADIONE, USP (VITAMIN K1)

DMF 35311979

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 1MG/0.5ML

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INJECTABLE;INJECTION | Approved: Sep. 30, 2026

No patent or exclusivity listings for this strength.