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MEPHYTON

NDA

PHYTONADIONE | N010104 | BAUSCH HEALTH AMERICAS INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Axinn on behalf of Zydus Pharmaceuticals (USA) Inc. FDA-2019-P-2240 Axinn, on behalf of Zydus Pharmaceuticals (USA) Inc., filed this citizen petition pursuant to Section 505 of the Federal Food, Drug and Cosmetic Act requesting that the FDA require manufacturers of Phytonadione Tablets ANDAs referencing Mephyton (NDA No. 010104) to provide data demonstrating compara	505(q)	2019-05-09	Denied	Axinn on behalf of Zydus Pharmaceuticals (USA) Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Jul 20, 2021	SUPPL -31	View Letter (PDF)
Jan 26, 2010	SUPPL -28	View Letter (PDF)
Mar 2, 2004	SUPPL -22	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#003 — 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.