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Spherusol

These highlights do not include all the information needed to use Spherusol safely and effectively. See full prescribing information for Spherusol . Spherule-Derived Skin Test Antigen- Spherusol Solution for Intradermal Injection Initial U.S. Approval: July 2011 Nielsen BioSciences, Inc. U.S. Lic. No. 1903 Mfd. by Allermed Laboratories, Inc. U.S. Lic. No. 0467

Approved
Approval ID

77108624-4771-4886-a3e2-b2625c444d1b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 1, 2023

Manufacturers
FDA

Nielsen BioSciences, Inc.

DUNS: 078835288

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Coccidioides immitis Spherule-Derived Skin Test Antigen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code59584-140
Application NumberBLA125354
Product Classification
M
Marketing Category
C73585
G
Generic Name
Coccidioides immitis Spherule-Derived Skin Test Antigen
Product Specifications
Route of AdministrationINTRADERMAL
Effective DateJune 13, 2022
FDA Product Classification

INGREDIENTS (5)

SODIUM CHLORIDEInactive
Quantity: .009 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM BORATEInactive
Quantity: .00014 g in 1 mL
Code: 91MBZ8H3QO
Classification: IACT
PHENOLInactive
Quantity: .0045 mL in 1 mL
Code: 339NCG44TV
Classification: IACT
WATERInactive
Quantity: .99 mL in 1 mL
Code: 059QF0KO0R
Classification: IACT
COCCIDIOIDES IMMITIS SPHERULEActive
Quantity: 12.7 ug in 1 mL
Code: ITY7G7Q744
Classification: ACTIB

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Spherusol - FDA Drug Approval Details