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ADRUCIL

NDA

FLUOROURACIL | N017959 | PHARMACIA AND UPJOHN CO

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 Qilu Pharmaceutical (Hainan) Co., Ltd. FDA-2022-P-0152 Qilu Pharmaceutical (Hainan) Co., Ltd. filed this petition under 21 C.F.R. 10.25(a) and 10.30 and Sections 505(j) and 505(w) of the FDC Act requesting that FDA determine whether ADRUCIL (fluorouracil) 50 mg/mL, approved under NDA 017959 and held by Pharmacia and Upjohn Co., was withdrawn for safety	505(q)	2022-02-14	Denied	Qilu Pharmaceutical (Hainan) Co.

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

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.

Products (1)

#001 — 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.