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Active ingredient

Temozolomide

71 finished FDA listings contain Temozolomide as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
TEMOZOLOMIDE
Dosage forms
Capsule, Injection, Powder, Lyophilized, For Solution
Routes
Intravenous, Oral
Manufacturers / labelers
12
Strengths listed
100 mg/1 · 140 mg/1 · 180 mg/1 · 2.5 mg/ml · 20 mg/1 · 250 mg/1 · 5 mg/1
Brand names in FDA listings
Temodar

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 37776

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
NDA 021029MERCK SHARP DOHME1999-08-116
NDA 022277MERCK SHARP DOHME2009-02-271
ANDA 201742SUN PHARM2014-02-126
ANDA 203691AMNEAL PHARMS2015-05-086
ANDA 203898EIRGEN2016-02-104
ANDA 206309RISING2016-04-276
ANDA 201528ACCORD HLTHCARE2017-02-276
ANDA 207658DEVA HOLDING AS2017-04-2624
ANDA 213328NIVAGEN2021-11-236
ANDA 210030HETERO LABS LTD V2024-08-236

Official labeling on DailyMed

Showing the 12 most recent of 20 labels.

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