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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Federal Trade Commission
Fish and Richardson
Harvard Business School
Cipla
Cerilliant
Deloitte
Merck
Chubb

Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040851

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NDA 040851 describes BENZONATATE, which is a drug marketed by Apotex Inc, Bionpharma Inc, Cspc Nbp Pharm Co, Mikart, Nesher Pharms, Orit Labs Llc, Strides Pharma, Sun Pharm Inds Inc, The Pharma Network, Thepharmanetwork Llc, and Zydus Pharms Usa, and is included in twelve NDAs. It is available from sixty-one suppliers. Additional details are available on the BENZONATATE profile page.

The generic ingredient in BENZONATATE is benzonatate. There are six drug master file entries for this compound. Sixty-two suppliers are listed for this compound. Additional details are available on the benzonatate profile page.
Summary for 040851
Tradename:BENZONATATE
Applicant:Mikart
Ingredient:benzonatate
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 040851
Suppliers and Packaging for NDA: 040851
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENZONATATE benzonatate CAPSULE;ORAL 040851 ANDA Mikart, Inc. 46672-280 N 46672-280-10
BENZONATATE benzonatate CAPSULE;ORAL 040851 ANDA Mikart, Inc. 46672-280 N 46672-280-50

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Nov 9, 2009TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength150MG
Approval Date:Nov 9, 2009TE:AARLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Nov 9, 2009TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Chubb
Cantor Fitzgerald
QuintilesIMS
Harvard Business School
Farmers Insurance
UBS
Julphar
Johnson and Johnson

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