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Last Updated: November 23, 2024

Details for New Drug Application (NDA): 091133


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NDA 091133 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 091133
Tradename:BENZONATATE
Applicant:Strides Pharma
Ingredient:benzonatate
Patents:0
Pharmacology for NDA: 091133
Suppliers and Packaging for NDA: 091133
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENZONATATE benzonatate CAPSULE;ORAL 091133 ANDA NCS HealthCare of KY, LLC dba Vangard Labs 0615-8403 0615-8403-05 15 CAPSULE in 1 BLISTER PACK (0615-8403-05)
BENZONATATE benzonatate CAPSULE;ORAL 091133 ANDA NCS HealthCare of KY, LLC dba Vangard Labs 0615-8403 0615-8403-21 21 CAPSULE in 1 BLISTER PACK (0615-8403-21)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Jul 30, 2015TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Jul 30, 2015TE:AARLD:No

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