MedPath

Sclerosol

Prescribing Information SCLEROSOL INTRAPLEURAL AEROSOL(sterile talc powder)NDC No. 63256-100-30

Approved
Approval ID

c89eb8fd-6c31-4f8b-8103-1f559424eda1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 18, 2012

Manufacturers
FDA

Bryan Corp

DUNS: 147033401

Products 1

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 Code63256-100
Application NumberNDA020587
Product Classification
M
Marketing Category
C73594
G
Generic Name
Talc
Product Specifications
Route of AdministrationINTRAPLEURAL
Effective DateOctober 18, 2012
FDA Product Classification

INGREDIENTS (2)

NORFLURANEInactive
Code: DH9E53K1Y8
Classification: IACT
TalcActive
Quantity: 4 g in 25.0 g
Code: 7SEV7J4R1U
Classification: ACTIB

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Sclerosol - FDA Drug Approval Details