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GLIADEL

NDA

CARMUSTINE | N020637 | AZURITY PHARMACEUTICALS 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

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain12 active DMFs1 inactive

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

JOHNSON MATTHEY PHARMACEUTICAL MATERIALSCARMUSTINE

DMF 102901993

AMPAC FINE CHEMICALS LLCCARMUSTINE (BCNU)

DMF 131691998

CHEMPACIFIC CORPCARMUSTINE DRUG SUBSTANCE

DMF 226372009

EMCURE PHARMACEUTICALS LTDCARMUSTINE USP

DMF 229052009

AGNO PHARMACARMUSTINE USP

DMF 301842017

MSN LABORATORIES PRIVATE LTDCARMUSTINE USP

DMF 311562016

JIANGSU HENGRUI PHARMACEUTICALS CO LTDCARMUSTINE USP NON STERILE BULK DRUG SUBSTANCE

DMF 320312017

APITORIA PHARMA PRIVATE LTDCARMUSTINE USP

DMF 323432017

NERPHARMA SRLCARMUSTINE DRUG SUBSTANCE

DMF 329222018

INTAS PHARMACEUTICALS LTDCARMUSTINE USP

DMF 337302019

NATCO PHARMA LTDCARMUSTINE

DMF 345472020

VANNSH LIFE SCIENCES PRIVATE LTDCARMUSTINE USP

DMF 386862023

BRISTOL LABORATORIES INC DIV BRISTOL MYERS COInactiveCARMUSTINE (BCNU) BULK & CARMUSTINE (BCNU) FOR INJ

DMF 20381973

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Dec 7, 2018	SUPPL -29	View Letter (PDF)
Nov 24, 2014	SUPPL -27	View Letter (PDF)
Aug 20, 2013	SUPPL -26	View Letter (PDF)
Jan 8, 2007	SUPPL -22	View Letter (PDF)
Mar 10, 2003	SUPPL -16	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 7.7MG

RLD

0 patents0 exclusivities▴

IMPLANT;INTRACRANIAL | Approved: Sep 23, 1996

No patent or exclusivity listings for this strength.