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FLUDARABINE PHOSPHATE

NDA

FLUDARABINE PHOSPHATE | N022137 | CAPLIN ONE LABS LTD

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 Hisun Pharmaceutical (Hangzhou) Co., Ltd. FDA-2023-P-5450 Hisun Pharmaceutical (Hangzhou) Co., Ltd. filed this citizen petition under 21 CFR 10.25(a) and 10.30 requesting that the FDA Commissioner determine whether the reference listed drug Fludarabine Phosphate Injection 50 mg/2mL (NDA N022137) was discontinued or withdrawn due to safety or efficacy reaso	Other	2023-12-13	Withdrawn	Hisun Pharmaceutical (Hangzhou) Co.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 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

3 letters from Drugs@FDA

Date	Submission	Document
Nov 21, 2024	SUPPL -15	View Letter (PDF)
Mar 2, 2011	SUPPL -3	View Letter (PDF)
Sep 25, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG/2ML (25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Sep 21, 2007

No patent or exclusivity listings for this strength.