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DTIC-DOME

NDA

DACARBAZINE | N017575 | BAYER HEALTHCARE PHARMACEUTICALS INC

2 strengths0 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

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Adjuvant Therapy of Skin Melanoma With Alpha Interferon and Naderin NCT07671495	Phase 2	Completed	MIPO Clinic	278	2014-01 → 2018-12

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

API Supply Chain2 active DMFs6 inactive

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

FUJIMOTO CHEMICALS CO LTDDACARBAZINE (BULK)

DMF 89141991

MATRIX PHARMACORP PRIVATE LTDDACARBAZINE USP

DMF 301072016

KYOWA HAKKO KOGYO CO LTDInactiveDACARBAZINE (

DMF 34571979

SOCIETE FRANCAISE D'ORGANOInactiveDACARBAZINE

DMF 47561982

KYOWA HAKKO KOGYO CO LTDInactiveDACARBAZINE

DMF 68191987

GMT FINE CHEMCALS SAInactiveDACARBAZINE USP

DMF 164112003

PLIVA LACHEMA ASInactiveDACARBAZINE

DMF 163262002

MAC CHEM PRODUCTS INDIA PVT LTDInactiveDACARBAZINE USP

DMF 256242011

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

Products (2)

Sort:

#001 — 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — 200MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

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