Purified Protein Derivative of Tuberculin Injectable Solution

Brand(s)
Aplisol, Tubersol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sanofi Pasteur Inc. (2013-03-20)
Oldest Current Product
1956-08-15
License(s)
BLA
RxNORM
INJECTABLE SOLUTION\PURIFIED PROTEIN DERIVATIVE OF TUBERCULIN
SPL Active
INTRADERMAL\INJECTION, SOLUTION\TUBERCULIN PURIFIED PROTEIN DERIVATIVE
SPL Moiety
INTRADERMAL\INJECTION, SOLUTION\TUBERCULIN PURIFIED PROTEIN DERIVATIVE

product(s) by strength(s)

purified protein derivative of tuberculin 50 unt/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1492810752TubersolBLASanofi Pasteur Inc.1956-08-15TUBERCULIN PURIFIED PROTEIN DERIVATIVEINTRADERMALINJECTION, SOLUTION103941a4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548682972TubersolBLAPhysicians Total Care, Inc.1956-08-15TUBERCULIN PURIFIED PROTEIN DERIVATIVEINTRADERMALINJECTION, SOLUTION49281075210394196d91ba3-9dfe-4420-a835-57647ea30b40

application(s)

#idtitleapprovedfda division
1103941Tuberculin, Purified Protein DerivativeTubersol Application1969-09-26CBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11e91a67c-1694-4523-9548-58f7a8871134 (view SPL)APLISOL (Tuberculin Purified Protein Derivative, Diluted [Stabilized Solution])prescriptionHuman PrescriptionPar Pharmaceutical Inc.2015-07-096420230104
296d91ba3-9dfe-4420-a835-57647ea30b40 (view SPL)Tuberculin Purified Protein Derivative(Mantoux)TUBERSOLprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2013-05-221548682972
3a4a732e9-b8ee-4e6d-8b9a-6a9d2c36bfcd (view SPL)Tuberculin Purified Protein Derivative(Mantoux)TUBERSOLprescriptionHuman PrescriptionSanofi Pasteur Inc.MANUFACTURE2013-03-203492810752

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