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Last Updated: January 24, 2022

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. It is available from one supplier. Additional details are available on the STERITALC profile page.

The generic ingredient in STERITALC is talc. There are eight drug master file entries for this compound. One supplier is 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
Suppliers and Packaging for NDA: 205555
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
STERITALC talc POWDER;INTRAPLEURAL 205555 NDA Novatech SA 62327-222 62327-222-42 4 VIAL, GLASS in 1 BOX (62327-222-42) > 50 mL in 1 VIAL, GLASS (62327-222-02)
STERITALC talc POWDER;INTRAPLEURAL 205555 NDA Novatech SA 62327-333 62327-333-43 4 VIAL, GLASS in 1 BOX (62327-333-43) > 10 mL in 1 VIAL, GLASS (62327-333-03)

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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Serving leading biopharmaceutical companies globally:

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Harvard Business School
McKinsey

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