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Last Updated: July 5, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 011210

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NDA 011210 describes TESSALON, which is a drug marketed by Pfizer and is included in one NDA. It is available from two suppliers. Additional details are available on the TESSALON profile page.

The generic ingredient in TESSALON is benzonatate. There are six drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the benzonatate profile page.
Summary for 011210
Formulation / Manufacturing:see details
Pharmacology for NDA: 011210
Suppliers and Packaging for NDA: 011210
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TESSALON benzonatate CAPSULE;ORAL 011210 NDA Pfizer Laboratories Div Pfizer Inc 0069-0122 0069-0122-01 100 CAPSULE in 1 BOTTLE (0069-0122-01)
TESSALON benzonatate CAPSULE;ORAL 011210 NDA Greenstone LLC 59762-1122 59762-1122-1 100 CAPSULE in 1 BOTTLE (59762-1122-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jun 25, 1999TE:RLD:Yes

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