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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 one supplier. 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. Fifty suppliers are listed for this compound. Additional details are available on the benzonatate profile page.

Summary for NDA: 011210

Tradename:
TESSALON
Applicant:
Pfizer
Ingredient:
benzonatate
Patents:0
Therapeutic Class:Respiratory Tract Agents
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Approved Prior to Jan 1, 1982TE:AARLD:No

Summary 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:No


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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