Viewing data from:

FLUOROURACIL

ANDA

FLUOROURACIL | A209219 | INGENUS PHARMACEUTICALS LLC

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 -5	View Letter (PDF)
Mar 26, 2024	SUPPL -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 500MG/10ML (50MG/ML)

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Dec 12, 2019

No patent or exclusivity listings for this strength.

#002 — 1GM/20ML (50MG/ML)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 12, 2019

Change History (4)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

INGENUS PHARMS LLC assumed applicant responsibility for fluorouracil (NDA 209219, oral solution) from NOVAST LABS.

Old: NOVAST LABS

New: INGENUS PHARMS LLC

MODIFIEDApplicant7/1/2026

Ingenus Pharms LLC became the applicant for Fluorouracil NDA 209219, replacing Novast Labs.

Old: NOVAST LABS

New: INGENUS PHARMS LLC

MODIFIEDApplicant Full Name7/1/2026

Ingenus Pharmaceuticals LLC replaced Novast Laboratories Ltd as the applicant for Fluorouracil NDA 209219, Supplement 002.

Old: NOVAST LABORATORIES LTD

New: INGENUS PHARMACEUTICALS LLC

MODIFIEDApplicant Full Name7/1/2026

INGENUS PHARMACEUTICALS LLC acquired NDA 209219 for fluorouracil from NOVAST LABORATORIES LTD.

Old: NOVAST LABORATORIES LTD

New: INGENUS PHARMACEUTICALS LLC