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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 211518


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NDA 211518 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 211518
Tradename:BENZONATATE
Applicant:Ascent Pharms Inc
Ingredient:benzonatate
Patents:0
Pharmacology for NDA: 211518
Physiological EffectDecreased Tracheobronchial Stretch Receptor Activity
Suppliers and Packaging for NDA: 211518
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENZONATATE benzonatate CAPSULE;ORAL 211518 ANDA Camber Pharmaceuticals, Inc. 31722-956 31722-956-01 100 CAPSULE in 1 BOTTLE (31722-956-01)
BENZONATATE benzonatate CAPSULE;ORAL 211518 ANDA Camber Pharmaceuticals, Inc. 31722-956 31722-956-05 500 CAPSULE in 1 BOTTLE (31722-956-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Feb 22, 2019TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength150MG
Approval Date:Feb 22, 2019TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Feb 22, 2019TE:AARLD:No

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Preferred Citation:

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