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PHYTONADIONE

ANDA

PHYTONADIONE | A217734 | AMNEAL EU LTD

1 strength0 unique patents0 unique exclusivities

API Supply Chain10 active DMFs

8 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

AMPHASTAR NANJING PHARMACEUTICALS INCPHYTONADIONE USP

DMF 379532023

ANHUI WANHE PHARMACEUTICAL CO LTDPHYTONADIONE (VITAMIN K1)

DMF 428962025

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

Products (1)

#001 — 10MG/ML

AB1

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jun 1, 2026

No patent or exclusivity listings for this strength.

Change History (1)

Recent changes detected for this application.

ADDED7/1/2026

Amneal's phytonadione product (NDA 217734, strength 001) was added to the FDA's drug database.

New: New record