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Chinese Patent Office
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Citi
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Argus Health
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Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040682

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NDA 040682 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 040682
Tradename:BENZONATATE
Applicant:Orit Labs Llc
Ingredient:benzonatate
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 040682
Suppliers and Packaging for NDA: 040682
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENZONATATE benzonatate CAPSULE;ORAL 040682 ANDA Major Pharmaceuticals 0904-6254 N 0904-6254-60
BENZONATATE benzonatate CAPSULE;ORAL 040682 ANDA Marlex Pharmaceuticals Inc 10135-632 N 10135-632-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Jul 30, 2007TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Jul 30, 2007TE:AARLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
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Daiichi Sankyo
Teva
Boehringer Ingelheim
Julphar
Healthtrust
US Army
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