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Chubb
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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040597

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NDA 040597 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-six 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-seven suppliers are listed for this compound. Additional details are available on the benzonatate profile page.

Summary for 040597

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 040597

Suppliers and Packaging for NDA: 040597

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENZONATATE benzonatate CAPSULE;ORAL 040597 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7678 0615-7678-39 30 CAPSULE in 1 BLISTER PACK (0615-7678-39)
BENZONATATE benzonatate CAPSULE;ORAL 040597 ANDA Major Pharmaceuticals, Inc. 0904-6564 0904-6564-60 100 CAPSULE in 1 BOTTLE (0904-6564-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Jun 8, 2007TE:AARLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Jun 8, 2007TE:AARLD:No


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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Moodys
Fish and Richardson
Johnson and Johnson
UBS
Teva
Julphar
QuintilesIMS
Express Scripts
Boehringer Ingelheim

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.

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