American house dust mite extract / European house dust mite extract Injectable Solution

Category(s)
other, prescription
SPL Type(s)
Human Prescription, Standardized Allergenic
Master SPL
Alk-Abello, Inc. (2015-10-08)
Oldest Current Product
1991-07-08
License(s)
BLA
RxNORM
INJECTABLE SOLUTION\AMERICAN HOUSE DUST MITE EXTRACT:EUROPEAN HOUSE DUST MITE EXTRACT
SPL Active
INTRADERMAL\CONCENTRATE\DERMATOPHAGOIDES FARINAE: DERMATOPHAGOIDES PTERONYSSINUS
SUBCUTANEOUS\INJECTION, SOLUTION\DERMATOPHAGOIDES FARINAE: DERMATOPHAGOIDES PTERONYSSINUS
SPL Moiety
INTRADERMAL\CONCENTRATE\DERMATOPHAGOIDES FARINAE: DERMATOPHAGOIDES PTERONYSSINUS
SUBCUTANEOUS\INJECTION, SOLUTION\DERMATOPHAGOIDES FARINAE: DERMATOPHAGOIDES PTERONYSSINUS

product(s) by strength(s)

american house dust mite extract 10000 au/ml / european house dust mite extract 10000 au/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002687002BLAAlk-Abello, Inc.1991-07-08DERMATOPHAGOIDES FARINAE, DERMATOPHAGOIDES PTERONYSSINUSSUBCUTANEOUSINJECTION, SOLUTION1030604a3539da-7f51-401b-8ac2-101b8a4658f4

american house dust mite extract 15000 au/ml / european house dust mite extract 15000 au/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1228400040BLAGreer Laboratories, Inc.2010-02-03DERMATOPHAGOIDES FARINAE, DERMATOPHAGOIDES PTERONYSSINUSINTRADERMALCONCENTRATE1018349b7f878e-613f-4831-9223-a6a07fb09f1b

american house dust mite extract 5000 au/ml / european house dust mite extract 5000 au/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002687003BLAAlk-Abello, Inc.1991-07-08DERMATOPHAGOIDES FARINAE, DERMATOPHAGOIDES PTERONYSSINUSSUBCUTANEOUSINJECTION, SOLUTION1030604a3539da-7f51-401b-8ac2-101b8a4658f4

american house dust mite extract 5000 unt/ml / european house dust mite extract 5000 unt/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1228400037BLAGreer Laboratories, Inc.2010-02-03DERMATOPHAGOIDES FARINAE, DERMATOPHAGOIDES PTERONYSSINUSINTRADERMALCONCENTRATE1018349b7f878e-613f-4831-9223-a6a07fb09f1b

application(s)

#idtitleapprovedfda division
1101834Insects (Whole Body) Mite Dermatophagoides farinae Application1958-09-15CBER
2103060Insects (Whole Body) Mite Dermatophagoides farinae Application1950-09-29CBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
14a3539da-7f51-401b-8ac2-101b8a4658f4 (view SPL)Standardized Mite, MixedotherStandardized AllergenicAlk-Abello, Inc.2015-10-084002687002, 002687003
29b7f878e-613f-4831-9223-a6a07fb09f1b (view SPL)These highlights do not include all the information needed to use Greer Standardized Mite Extracts safely and effectively. See full prescribing information for Greer Standardized Mite Extracts.Standardized Mite Extract (Dermatophagoides farinae) Standardized Mite Extract (Dermatophagoides pteronyssinus) Standardized Mite Extract Mixture (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Solution for percutaneous, intradermal, or subcutaneous administrationInitial U.S. Approval: 1987prescriptionHuman PrescriptionGreer Laboratories, Inc.MANUFACTURE2013-01-292228400037, 228400040, 228400033, 228400034, 228400035, 228400036, 228400038, 228400039house dust mite extract, Dermatophagoides pteronyssinus Injectable Solution
house dust mite extract, Dermatophagoides farinae Injectable Solution

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