Last Updated: November 8, 2026

Details for New Drug Application (NDA): 072265

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NDA 072265 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, Ph Health, Pliva, Quagen, Quantum Pharmics, Tp Anda Holdings, and Usl Pharma, and is included in twenty-eight NDAs. It is available from twenty-three suppliers. Additional details are available on the BENZTROPINE MESYLATE profile page.

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

Summary for 072265

Tradename:	BENZTROPINE MESYLATE
Applicant:	Epic Pharma Llc
Ingredient:	benztropine mesylate
Patents:	0

Medical Subject Heading (MeSH) Categories for 072265

Antiparkinson Agents
Dopamine Uptake Inhibitors
Muscarinic Antagonists
Parasympatholytics

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	1MG
Approval Date:	Feb 27, 1989	TE:	AA	RLD:	No

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