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CARAC

NDA

FLUOROURACIL | N020985 | EXTROVIS AG

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

500 trials from ClinicalTrials.gov — 10 recruiting, 43 active, 445 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.NCT03504397	Phase 3	Active	Astellas Pharma Global Development, Inc.	565	2018-06-21 → 2026-09-30
Vitamin D3 With Chemotherapy and Bevacizumab in Treating Patients With Advanced or Metastatic Colorectal Cancer NCT04094688	Phase 3	Active	Alliance for Clinical Trials in Oncology	455	2019-10-29 → 2026-07-01
Chemoradiotherapy Versus Esophagectomy After Endoscopic Resection for Superficial Esophageal Squamous Cell Carcinoma NCT03306901	N/A	Active	Samsung Medical Center	240	2017-10-20 → 2033-12-31
Trial of Preoperative Therapy for Gastric and Esophagogastric Junction Adenocarcinoma NCT01924819	Phase 2/3	Active	Australasian Gastro-Intestinal Trials Group	574	2009-09 → 2026-12-31
Panther: A Study Comparing Biweekly and Tailored EC-T Versus Three Weekly FEC-T in Breast Cancer Patients NCT00798070	Phase 3	Active	Karolinska University Hospital	2,017	2007-02 → 2028-01
Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma NCT00588770	Phase 3	Active	National Cancer Institute (NCI)	403	2008-08-08 → 2027-02-20
Combination Chemotherapy With or Without Fluorouracil and/or Pegfilgrastim in Treating Women With Node-Positive Breast Cancer NCT00433420	Phase 3	Active	IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy	2,000	2003-04 → 2027-12
Combination Chemotherapy and Bevacizumab With the NovoTTF-100L(P) System in Treating Participants With Advanced, Recurrent, or Refractory Hepatic Metastatic Cancer NCT03203525	Phase 1	Active	M.D. Anderson Cancer Center	38	2020-06-23 → 2026-12-31
A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer NCT03505320	Phase 2	Active	Astellas Pharma Global Development, Inc.	143	2018-06-29 → 2027-11-30
Liposomal iRInotecan, Carboplatin or oXaliplatin for Esophagogastric Cancer NCT03764553	Phase 2	Active	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	320	2019-05-01 → 2026-07-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$42.62

per gm

Lowest NADAC/Unit

$42.62

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
75907016911FLUOROURACIL 0.5% CREAM	$42.62	GM	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$859.12

Highest Price

$859.12

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
75907-0169-11FLUOROURACIL 0.5% CREAM,TOP	$859.12	FSS	Dr. Reddys Laboratories	09/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

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

4 letters from Drugs@FDA

Date	Submission	Document
May 4, 2026	SUPPL -21	View Letter (PDF)
May 27, 2022	SUPPL -19	View Letter (PDF)
Dec 19, 2003	SUPPL -4	View Letter (PDF)
Oct 27, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.5%

RLD

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Oct 27, 2000

No patent or exclusivity listings for this strength.