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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 040627


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NDA 040627 describes BENZONATATE, which is a drug marketed by Acella, Ascent Pharms Inc, Bionpharma, Chartwell Rx, Cspc-nbp Pharm, Heritage Pharms Labs, Mikart, Nesher Pharms, Onesource Specialty, Puracap Pharm Llc, Sun Pharm Inds Inc, Thepharmanetwork Llc, and Zydus Pharms Usa, and is included in thirteen NDAs. It is available from forty-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. Forty-seven suppliers are listed for this compound. Additional details are available on the benzonatate profile page.
Summary for 040627
Tradename:BENZONATATE
Applicant:Thepharmanetwork Llc
Ingredient:benzonatate
Patents:0
Pharmacology for NDA: 040627
Physiological EffectDecreased Tracheobronchial Stretch Receptor Activity
Suppliers and Packaging for NDA: 040627
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENZONATATE benzonatate CAPSULE;ORAL 040627 ANDA QPharma, Inc. 42708-082 42708-082-21 21 CAPSULE in 1 BOTTLE (42708-082-21)
BENZONATATE benzonatate CAPSULE;ORAL 040627 ANDA Northwind Pharmaceuticals, LLC 51655-776 51655-776-52 30 CAPSULE in 1 BOTTLE, PLASTIC (51655-776-52)

Profile for product number 001

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

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Jul 25, 2007TE:AARLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength150MG
Approval Date:Sep 24, 2014TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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