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Generated: October 16, 2018

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Details for New Drug Application (NDA): 081297

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NDA 081297 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 081297
Tradename:BENZONATATE
Applicant:Bionpharma Inc
Ingredient:benzonatate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 081297
Suppliers and Packaging for NDA: 081297
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENZONATATE benzonatate CAPSULE;ORAL 081297 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-1349 0615-1349-39 30 CAPSULE in 1 BLISTER PACK (0615-1349-39)
BENZONATATE benzonatate CAPSULE;ORAL 081297 ANDA RPK Pharmaceuticals, Inc. 53002-0411 53002-0411-1 10 CAPSULE in 1 BOTTLE (53002-0411-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Jan 29, 1993TE:AARLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Oct 30, 2007TE:AARLD:No

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