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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
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Boehringer Ingelheim

Generated: March 17, 2018

DrugPatentWatch Database Preview

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 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 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-two suppliers are listed for this compound. Additional details are available on the benztropine mesylate profile page.
Summary for 091525
Applicant:Navinta Llc
Ingredient:benztropine mesylate
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 091525
Medical Subject Heading (MeSH) Categories for 091525
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 N 68382-860-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Feb 5, 2013TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Express Scripts
US Department of Justice
Argus Health
Farmers Insurance

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