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Generated: October 16, 2018

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Details for New Drug Application (NDA): 040749

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NDA 040749 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 040749
Tradename:BENZONATATE
Applicant:Thepharmanetwork Llc
Ingredient:benzonatate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040749
Suppliers and Packaging for NDA: 040749
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BENZONATATE benzonatate CAPSULE;ORAL 040749 ANDA Liberty Pharmaceuticals, Inc. 0440-7186 0440-7186-01 100 CAPSULE in 1 BOTTLE (0440-7186-01)
BENZONATATE benzonatate CAPSULE;ORAL 040749 ANDA Liberty Pharmaceuticals, Inc. 0440-7186 0440-7186-05 500 CAPSULE in 1 BOTTLE (0440-7186-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Jul 25, 2007TE:AARLD:No

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