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FLUOROURACIL

ANDA

FLUOROURACIL | A203609 | SAGENT PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

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 3, 2026	SUPPL -15	View Letter (PDF)
Mar 26, 2024	SUPPL -14	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — 2.5GM/50ML (50MG/ML)

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Feb 17, 2016

No patent or exclusivity listings for this strength.

#002 — 5GM/100ML (50MG/ML)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Feb 17, 2016