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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 088877

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NDA 088877 describes BENZTROPINE MESYLATE, which is a drug marketed by Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Luitpold, Navinta Llc, Aiping Pharm Inc, Chartwell Rx, Endo Operations, Epic Pharma Llc, Invagen Pharms, Lannett Co Inc, Leading, Nuvo Pharm, Oxford Pharms, Pliva, Quantum Pharmics, and Usl Pharma, and is included in twenty-seven NDAs. It is available from twenty 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 suppliers are listed for this compound. Additional details are available on the benztropine mesylate profile page.

Summary for 088877

Tradename:	BENZTROPINE MESYLATE
Applicant:	Lannett Co Inc
Ingredient:	benztropine mesylate
Patents:	0

Medical Subject Heading (MeSH) Categories for 088877

Antiparkinson Agents
Dopamine Uptake Inhibitors
Muscarinic Antagonists
Parasympatholytics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Apr 11, 1985	TE:		RLD:	No

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