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OFORTA

NDA

FLUDARABINE PHOSPHATE | N022273 | SANOFI AVENTIS US 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 Chain6 active DMFs6 inactive

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

TAPI NL BVFLUDARABINE PHOSPHATE

DMF 157422001

ZHEJIANG HISUN PHARMACEUTICAL CO LTDFLUDARABINE PHOSPHATE USP

DMF 168072003

HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTDFludarabine Phosphate Drug Substance

DMF 210472007

EXPLORA LABORATORIES SAFLUDARABINE PHOSPHATE

DMF 230062009

HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTDFLUDARABINE PHOSPHATE DRUG SUBSTANCE

DMF 345092020

BIOCARE PHARMACEUTICAL LTDFLUDARABINE PHOSPHATE (REFINED)

DMF 351732020

ASH STEVENS INCInactiveFLUDARABINE PHOSPHATE

DMF 82411989

BAYER SCHERING PHARMA AGInactiveFLUDARABINE PHOSPHATE

DMF 149242000

ASH STEVENS INCInactiveFLUDARABINE PHOSPHATE (ASP)

DMF 155422001

RELIABLE BIOPHARMACEUTICAL LLCInactiveFLUDARABINE PHOSPHATE

DMF 171362004

EUTICALS SPAInactiveFLUDARABINE PHOSPHATE

DMF 173742004

AXITEC CO LTDInactiveFLUDARABINE PHOSPHATE USP, NON-STERILE BULK DRUG

DMF 196142006

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Nov 24, 2009	SUPPL -1	View Letter (PDF)
Dec 29, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 18, 2008

No patent or exclusivity listings for this strength.