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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 202765


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NDA 202765 describes BENZONATATE, which is a drug marketed by Acella, Ascent Pharms Inc, Bionpharma, Chartwell Rx, Cspc-nbp Pharm, Heritage Pharms Labs, Mikart, Nesher Pharms, Puracap Pharm Llc, Strides Pharma, Sun Pharm Inds Inc, Thepharmanetwork Llc, and Zydus Pharms Usa, and is included in thirteen NDAs. It is available from forty-four 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-four suppliers are listed for this compound. Additional details are available on the benzonatate profile page.
Summary for 202765
Tradename:BENZONATATE
Applicant:Cspc-nbp Pharm
Ingredient:benzonatate
Patents:0
Pharmacology for NDA: 202765
Suppliers and Packaging for NDA: 202765
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENZONATATE benzonatate CAPSULE;ORAL 202765 ANDA A-S Medication Solutions 50090-4968 50090-4968-0 15 CAPSULE in 1 BOTTLE (50090-4968-0)
BENZONATATE benzonatate CAPSULE;ORAL 202765 ANDA A-S Medication Solutions 50090-4969 50090-4969-0 20 CAPSULE in 1 BOTTLE (50090-4969-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Jul 31, 2015TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Aug 25, 2017TE:AARLD:No

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