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Chinese Patent Office
Medtronic
Fuji
Federal Trade Commission
Mallinckrodt
US Department of Justice
Queensland Health
Colorcon
Teva
Argus Health

Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090233

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NDA 090233 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 090233
Tradename:BENZTROPINE MESYLATE
Applicant:Fresenius Kabi Usa
Ingredient:benztropine mesylate
Patents:0
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 090233
Medical Subject Heading (MeSH) Categories for 090233
Suppliers and Packaging for NDA: 090233
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENZTROPINE MESYLATE benztropine mesylate INJECTABLE;INJECTION 090233 ANDA Nexus Pharmaceuticals Inc 14789-300 E 14789-300-02
BENZTROPINE MESYLATE benztropine mesylate INJECTABLE;INJECTION 090233 ANDA Fresenius Kabi USA, LLC 63323-970 E 63323-970-02

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Jul 28, 2009TE:APRLD:No

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US Army
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