Deeper Knowledge, Faster

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Obtain formulation and manufacturing information
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Covington
Baxter
Medtronic
Johnson and Johnson
Mallinckrodt
Cipla
Novartis
AstraZeneca
QuintilesIMS
Accenture

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040851

« Back to Dashboard

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 fifty-seven 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. Fifty-eight 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 46672-280-50 500 CAPSULE in 1 BOTTLE (46672-280-50)
BENZONATATE benzonatate CAPSULE;ORAL 040851 ANDA Mikart, Inc. 46672-280 46672-280-10 100 CAPSULE in 1 BOTTLE (46672-280-10)

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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Fuji
US Army
Accenture
McKinsey
Teva
Johnson and Johnson
Deloitte
Cipla
Colorcon

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

botpot