NDC 69448-001

Mutamycin 5 mg per 10 mL injection, powder, lyophilized, for solution

On the label: Accord BioPharma Inc..

India: 2

Where it's made

FactoryWhereRoleLast FDA inspection
Intas Pharmaceuticals LimitedAhmedabad, IndiaMakes it and tests it No problems foundJul 12, 2024 · 10 inspections
Intas Pharmaceuticals LimitedAhmedabad, IndiaMakes it and tests it Serious problems, FDA actionDec 2, 2022 · 7 inspections, 1 with FDA action

Product details

Generic drug
Mitomycin: every company that makes it
Form
injection, powder, lyophilized, for solution, intravenous
Strength
5 mg per 10 mL
Approval
ANDA ANDA064144
On the market since
Jul 25, 2017
Package NDCs
69448-001-05
Official label
DailyMed (National Library of Medicine), updated Mar 12, 2025

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