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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 089058

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NDA 089058 describes BENZTROPINE MESYLATE, which is a drug marketed by Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Luitpold, Navinta Llc, Aiping Pharm Inc, Chartwell Rx, Epic Pharma Llc, Invagen Pharms, Lannett Co Inc, Leading, Nuvo Pharm, Oxford Pharms, Ph Health, Pliva, Quagen, Quantum Pharmics, and Usl Pharma, and is included in twenty-eight NDAs. It is available from twenty-one suppliers. Additional details are available on the BENZTROPINE MESYLATE profile page.

The generic ingredient in BENZTROPINE MESYLATE is benztropine mesylate. There are seven drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the benztropine mesylate profile page.

Summary for 089058

Tradename:	BENZTROPINE MESYLATE
Applicant:	Pliva
Ingredient:	benztropine mesylate
Patents:	0

Medical Subject Heading (MeSH) Categories for 089058

Antiparkinson Agents
Dopamine Uptake Inhibitors
Muscarinic Antagonists
Parasympatholytics

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.5MG
Approval Date:	Aug 10, 1988	TE:	AA	RLD:	No

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