Viewing data from:

MUSTARGEN

NDA

MECHLORETHAMINE HYDROCHLORIDE | N006695 | RECORDATI RARE DISEASES INC

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

4 trials from ClinicalTrials.gov — 2 recruiting, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Brentuximab Vedotin and Bendamustine for the Treatment of Relapsed or Refractory Follicular Lymphoma NCT04587687	Phase 2	Recruiting	University of California, Davis	23	2020-12-04 → 2028-05
Study of Pembrolizumab With Bendamustine in Hodgkin Lymphoma NCT04510636	Phase 2	Recruiting	University Health Network, Toronto	40	2021-12-20 → 2026-11-01
Brentuximab Vedotin and Bendamustine for the Treatment of Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma (ALCL)NCT01657331	Phase 1/2	Completed	Columbia University	65	2012-07 → 2018-06
Mesothelin-Specific T-Cells (FH-TCR-Tᴍsʟɴ) for the Treatment of Metastatic Pancreatic Ductal Adenocarcinoma NCT04809766	Phase 1	Terminated	Fred Hutchinson Cancer Center	9	2021-12-14 → 2025-01-15

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain1 active DMF1 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

HAS HEALTHCARE ADVANCED SYNTHESIS SAMECHLORETHAMINE HYDROCHLORIDE

DMF 376872023

SAFC INCInactiveMECHLORETHAMINE HYDROCHLORIDE

DMF 101031993

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 2, 2004	SUPPL -31	View Letter (PDF)
Mar 26, 2003	SUPPL -30	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG/VIAL

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.