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Serving leading biopharmaceutical companies globally:

Julphar
Boehringer Ingelheim
Novartis
Johnson and Johnson
Farmers Insurance
Deloitte
US Army
QuintilesIMS
AstraZeneca
Healthtrust

Generated: February 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 072264

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NDA 072264 describes BENZTROPINE MESYLATE, which is a drug marketed by Fresenius Kabi Usa, Hikma Farmaceutica, Luitpold, Navinta Llc, Aspen Global Inc, Chartwell Rx, Epic Pharma Llc, Invagen Pharms, Lannett Holdings Inc, Leading Pharma Llc, Oxford Pharms, Pliva, Quantum Pharmics, Usl Pharma, and Vintage, and is included in twenty-seven NDAs. It is available from thirty-one suppliers. Additional details are available on the BENZTROPINE MESYLATE profile page.

The generic ingredient in BENZTROPINE MESYLATE is benztropine mesylate. There are five drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the benztropine mesylate profile page.
Summary for 072264
Tradename:BENZTROPINE MESYLATE
Applicant:Epic Pharma Llc
Ingredient:benztropine mesylate
Patents:0
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 072264
Medical Subject Heading (MeSH) Categories for 072264
Suppliers and Packaging for NDA: 072264
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENZTROPINE MESYLATE benztropine mesylate TABLET;ORAL 072264 ANDA Major Pharmaceuticals 0904-1055 N 0904-1055-61
BENZTROPINE MESYLATE benztropine mesylate TABLET;ORAL 072264 ANDA Cardinal Health 55154-1347 E 55154-1347-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Feb 27, 1989TE:AARLD:No

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