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FLAGYL I.V. RTU IN PLASTIC CONTAINER

NDA

METRONIDAZOLE | N018657 | BAXTER HEALTHCARE CORP

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs15 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CORDEN PHARMA BERGAMO SPAMETRONIDAZOLE USP

DMF 36091979

UNICHEM LABORATORIES LTDMETRONIDAZOLE USP

DMF 162632002

RHONE POULENC INCInactiveMETRONIDAZOLE

DMF 7801964

COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SARLInactiveMETRONIDAZOLE

DMF 21861973

UNIQUE CHEMICALSInactiveMETRONIDAZOLE

DMF 36751979

MCGAW INCInactiveMETRONIDAZOLE INJECTION 0.5%,MNFG IN SOUTHERN CALIFORNIA FACILITIES

DMF 39041980

MEDIMPEX NORTH AMERICA INCInactiveMETRONIDAZOLE USP XX

DMF 46721982

TIANJIN HEBEI PHARMACEUTICAL FACTORYInactiveMETRONIDAZOLE

DMF 49271983

UNICHEM LABORATORIES LTDInactiveMETRONIDAZOLE USP

DMF 57831985

UNICHEM LABORATORIES LTDInactiveMETRONIDAZOLE BENZOATE

DMF 63561986

FDC PRIVATE LTDInactiveMETRONIDAZOLE U.S.P. XXI

DMF 70241987

ZAKLADY FARMACEUTYCZNE POLPHARMA SAInactiveMETRONIDAZOLE

DMF 92941991

SIFAVITOR SRLInactiveMETRONIDAZOLE BENZOATE

DMF 94061991

TIANJIN ZHONGAN PHARMACEUTICAL CO LTDInactiveMETRONIDAZOLE

DMF 163802003

HEC PHARM COInactiveMETRONIDAZOLE USP, NON-STERILE BULK FORM

DMF 194422006

WUHAN WUYAO PHARMACEUTICAL CO LTDInactiveMETRONIDAZOLE

DMF 234212009

HUBEI HONGYUAN PHARMACEUTICAL CO LTDInactiveMETRONIDAZOLE

DMF 266582012

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

Approval Letters

13 letters from Drugs@FDA

Date	Submission	Document
Jun 25, 2025	SUPPL -45	View Letter (PDF)
Mar 18, 2025	SUPPL -43	View Letter (PDF)
Jul 9, 2024	SUPPL -42	View Letter (PDF)
Dec 20, 2021	SUPPL -39	View Letter (PDF)
Mar 9, 2021	SUPPL -38	View Letter (PDF)
Dec 6, 2017	SUPPL -36	View Letter (PDF)
Jul 14, 2015	SUPPL -34	View Letter (PDF)
Oct 25, 2013	SUPPL -32	View Letter (PDF)
May 30, 2012	SUPPL -28	View Letter (PDF)
Aug 9, 2011	SUPPL -31	View Letter (PDF)
Nov 19, 2009	SUPPL -29	View Letter (PDF)
Jun 7, 2004	SUPPL -27	View Letter (PDF)
Jun 7, 2004	SUPPL -26	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 500MG/100ML

RLDAP

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.