Coccidioides immitis spherule Injectable Solution

Brand(s)
Spherusol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Nielsen Biosciences, Inc. (2014-10-08)
Oldest Current Product
2011-07-29
License(s)
BLA
RxNORM
INJECTABLE SOLUTION\COCCIDIOIDES IMMITIS SPHERULE
SPL Active
INTRADERMAL\INJECTION, SOLUTION\COCCIDIOIDES IMMITIS SPHERULE
SPL Moiety
INTRADERMAL\INJECTION, SOLUTION\COCCIDIOIDES IMMITIS SPHERULE

product(s) by strength(s)

coccidioides immitis spherule 0.0127 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1595840140SpherusolBLANielsen Biosciences, Inc.2011-07-29COCCIDIOIDES IMMITIS SPHERULEINTRADERMALINJECTION, SOLUTION12535477108624-4771-4886-a3e2-b2625c444d1b

application(s)

#idtitleapprovedtradenamesfda division
1125354Coccidioides immitis Spherule-Derived Skin Test Antigen Application2011-07-29SpherusolCBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
177108624-4771-4886-a3e2-b2625c444d1b (view SPL)These highlights do not include all the information needed to use Spherusol safely and effectively. See full prescribing information for Spherusol . Coccidioides immitis 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. 0467prescriptionHuman PrescriptionNielsen Biosciences, Inc.manufacture2014-10-085595840140

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII