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Active ingredient

Mitomycin

36 finished FDA listings contain Mitomycin as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
MITOMYCIN
Dosage forms
Injection, Powder, Lyophilized, For Solution
Routes
Intravenous
Manufacturers / labelers
11
Strengths listed
20 mg/1 · 20 mg/40ml · 40 mg/1 · 40 mg/80ml · 5 mg/10ml
Brand names in FDA listings
Mutamycin

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 632

Drugs@FDA applications

Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.

ApplicationSponsorOriginal approvalListings
ANDA 064117HIKMA1995-04-194
ANDA 064144ACCORD HLTHCARE1998-04-308
ANDA 202670RK PHARMA2017-10-135
ANDA 203386RK PHARMA2017-10-131
ANDA 215687GLAND2021-10-206
ANDA 214504MEITHEAL2022-09-061
ANDA 214505MEITHEAL2022-09-082
ANDA 216648GLAND2022-11-223
ANDA 216732EUGIA PHARMA2023-10-306

Official labeling on DailyMed

Showing the 12 most recent of 19 labels.

Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.