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Generated: September 19, 2018

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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, Thepharmanetwork Llc, and Zydus Pharms Usa, and is included in twelve NDAs. It is available from sixty 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. Sixty-one suppliers are listed for this compound. Additional details are available on the benzonatate profile page.
Summary for 040597
Tradename:BENZONATATE
Applicant:Zydus Pharms Usa
Ingredient:benzonatate
Patents:0
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)

Profile for product number 001

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

Profile for product number 002

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

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