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Generated: November 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205555

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NDA 205555 describes STERITALC, which is a drug marketed by Novatech Sa and is included in one NDA. Additional details are available on the STERITALC profile page.

The generic ingredient in STERITALC is talc. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the talc profile page.
Summary for 205555
Tradename:STERITALC
Applicant:Novatech Sa
Ingredient:talc
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 205555

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAPLEURALStrength2GM/VIAL
Approval Date:May 1, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:May 1, 2024
Regulatory Exclusivity Use:TO DECREASE THE RECURRENCE OF MALIGNANT PLEURAL EFFUSIONS IN SYMPTOMATIC PATIENTS FOLLOWING MAXIMAL DRAINAGE OF THE PLEURAL EFFUSION
Regulatory Exclusivity Expiration:May 1, 2024
Regulatory Exclusivity Use:TO DECREASE THE RECURRENCE OF PNEUMOTHORAX IN ADULTS

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAPLEURALStrength3GM/VIAL
Approval Date:May 1, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:May 1, 2024
Regulatory Exclusivity Use:TO DECREASE THE RECURRENCE OF MALIGNANT PLEURAL EFFUSIONS IN SYMPTOMATIC PATIENTS FOLLOWING MAXIMAL DRAINAGE OF THE PLEURAL EFFUSION

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