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Active ingredient

Benztropine

56 finished FDA listings contain Benztropine as their only active ingredient.

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FDA NDC Directory

Ingredient names as written by FDA
BENZTROPINE MESYLATE
Dosage forms
Injection, Injection, Solution, Tablet
Routes
Intramuscular, Intravenous, Oral
Manufacturers / labelers
23
Strengths listed
.5 mg/1 · 1 mg/1 · 1 mg/ml · 2 mg/1
Brand names in FDA listings
Benztropine Mesylate

RxNorm (National Library of Medicine)

Ingredient concept RxCUI 1424

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 081265CHARTWELL RX1992-01-233
ANDA 040103AIPING PHARM INC1996-12-125
ANDA 040715PH HEALTH2007-08-2719
ANDA 090233FRESENIUS KABI USA2009-07-281
ANDA 090287HIKMA FARMACEUTICA2009-08-311
ANDA 090294INVAGEN PHARMS2010-03-293
ANDA 090168LEADING2012-11-288
ANDA 091525NAVINTA LLC2013-02-052
ANDA 204713NUVO PHARM2015-04-146
ANDA 209442HIKMA2021-10-141
ANDA 212694QUAGEN2025-02-116

Official labeling on DailyMed

Showing the 12 most recent of 34 labels.

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