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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 091525

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NDA 091525 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 091525

Tradename:	BENZTROPINE MESYLATE
Applicant:	Navinta Llc
Ingredient:	benztropine mesylate
Patents:	0

Pharmacology for NDA: 091525

Mechanism of Action	Cholinergic Antagonists Histamine Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 091525

Antiparkinson Agents
Dopamine Uptake Inhibitors
Muscarinic Antagonists
Parasympatholytics

Suppliers and Packaging for NDA: 091525

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BENZTROPINE MESYLATE	benztropine mesylate	INJECTABLE;INJECTION	091525	ANDA	Zydus Pharmaceuticals USA Inc.	68382-860	68382-860-10	5 VIAL in 1 CARTON (68382-860-10) / 2 mL in 1 VIAL (68382-860-02)
BENZTROPINE MESYLATE	benztropine mesylate	INJECTABLE;INJECTION	091525	ANDA	Navinta LLC	68475-512	68475-512-02	5 VIAL in 1 CARTON (68475-512-02) / 2 mL in 1 VIAL (68475-512-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/ML
Approval Date:	Feb 5, 2013	TE:	AP	RLD:	No

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