Steritalc
These highlights do not include all the information needed to use STERITALC® safely and effectively. See full prescribing information for STERITALC®. STERITALC® (talc), powder, for intrapleural use Initial U.S. Approval: 2003
Approved
Approval ID
c94e51d9-beef-4b06-e053-2a95a90a754a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 12, 2023
Manufacturers
FDA
Novatech SA
DUNS: 777211640
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Talc
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62327-333
Application NumberNDA205555
Product Classification
M
Marketing Category
C73594
G
Generic Name
Talc
Product Specifications
Route of AdministrationINTRAPLEURAL
Effective DateJanuary 12, 2023
FDA Product Classification
INGREDIENTS (1)
TALCActive
Quantity: 3 g in 10 mL
Code: 7SEV7J4R1U
Classification: ACTIB
Talc
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62327-444
Application NumberNDA205555
Product Classification
M
Marketing Category
C73594
G
Generic Name
Talc
Product Specifications
Route of AdministrationINTRAPLEURAL
Effective DateJanuary 12, 2023
FDA Product Classification
INGREDIENTS (1)
TALCActive
Quantity: 4 g in 50 mL
Code: 7SEV7J4R1U
Classification: ACTIB
Talc
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62327-222
Application NumberNDA205555
Product Classification
M
Marketing Category
C73594
G
Generic Name
Talc
Product Specifications
Route of AdministrationINTRAPLEURAL
Effective DateJanuary 12, 2023
FDA Product Classification
INGREDIENTS (1)
TALCActive
Quantity: 2 g in 50 mL
Code: 7SEV7J4R1U
Classification: ACTIB