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FLUOROPLEX

NDA

FLUOROURACIL | N016988 | CHARTWELL RX SCIENCES LLC

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 Chain4 active DMFs3 inactive

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

AMCOL HEALTH AND BEAUTY SOLUTIONS INCFLUOROURACIL IN MICROSPONGE® POLYMER (FLUROURACIL IN METHYL METHACRYLATE/DIMETHACRYLATE CROSSPOLYMER)

DMF 127381997

NANTONG JINGHUA PHARMACEUTICAL CO LTDFLUOROURACIL USP

DMF 184782005

IMCD SWITZERLAND AGFLUOROURACIL

DMF 217742008

FUJIAN SOUTH PHARMACEUTICAL CO LTDFLUOROURACIL

DMF 409392024

ANDARD MOUNT INTERNATIONAL LTDInactiveFLUOROURACIL

DMF 60981985

TEIKOKU CHEM INDUSTRYInactiveFLUOROURACIL

DMF 71791987

NANTONG GENERAL PHARMACEUTICAL FACTORYInactiveFLUOROURACIL

DMF 178322004

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Mar 1, 2022	SUPPL -33	View Letter (PDF)
Jul 26, 2016	SUPPL -30	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

RLD

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.