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MUTAMYCIN

NDA

MITOMYCIN | N050450 | BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO

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

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain6 active DMFs3 inactive

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

TAPI NL BVMITOMYCIN

DMF 137911998

ZHEJIANG HISUN PHARMACEUTICAL CO LTDMITOMYCIN USP (ALTERNATIVE PROCESS)

DMF 256592011

CONCORD BIOTECH LTDMITOMYCIN USP

DMF 336622019

CHEMWERTH INCMITOMYCIN

DMF 338112019

WUXI FORTUNE PHARMACEUTICAL CO LTDMITOMYCIN

DMF 348662020

HUBEI HONCH PHARMACEUTICAL CO LTDMITOMYCIN

DMF 374622023

KYOWA HAKKO KOGYO CO LTDInactiveMITOMYCIN

DMF 135211998

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveMITOMYCIN USP

DMF 137831998

MICROBIOPHARM JAPAN CO LTDInactiveMITOMYCIN

DMF 137851998

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

Products (2)

Sort:

#001 — 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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#002 — 20MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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