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Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

NOVANTRONE

NDA

Tentative Approval

MITOXANTRONE HYDROCHLORIDE | N021120 | SERONO INC

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 Chain3 active DMFs4 inactive

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

CHONGQING CARELIFE PHARMACEUTICAL CO LTDMITOXANTRONE HYDROCHLORIDE USP

DMF 122621996

IDT AUSTRALIA LTDMITOXANTRONE HYDROCHLORIDE USP

DMF 123281997

CHONGQING CARELIFE PHARMACEUTICAL CO LTDMITOXANTRONE HYDROCHLORIDE

DMF 432532025

CIPLA LTDInactiveMITOXANTRONE HYDROCHLORIDE

DMF 108581994

SYNTHESIA ASInactiveMITOXANTRONE HYDROCHLORIDE USP

DMF 120461996

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveMITOXANTRONE HYDROCHLORIDE USP

DMF 158792002

CIPLA LTDInactiveMITOXANTRONE HYDROCHLORIDE USP

DMF 193092007

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 10, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 2MG BASE/ML

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INJECTABLE; INJECTION | Approved: 2000-10-13 00:00:00

No patent or exclusivity listings for this strength.