Atropine / pralidoxime Auto-Injector

Brand(s)
Duodote
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
U.S. Army Medical Research And Development Command (Mcmr-Rcq-Hr) (2009-09-30)
Oldest Current Product
2006-09-06
License(s)
NDA
RxNORM
AUTO-INJECTOR\ATROPINE:PRALIDOXIME
FDAOB
INTRAMUSCULAR\INJECTION\ATROPINE: PRALIDOXIME CHLORIDE

product(s) by strength(s)

2.7 ml atropine 0.778 mg/ml / pralidoxime chloride 222 mg/ml auto-injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)dose formapplicationspl
1117040620DuodoteNDAU.S. Army Medical Research And Development Command (Mcmr-Rcq-Hr)2006-09-06ATROPINE, PRALIDOXIME CHLORIDEKITNDA021983241f42a0-1a33-40e8-8221-201767d999e5

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1NDA021175ATNAATrueUS ARMY MEDICAL RESEARCH MATERIEL COMMAND2002-01-17NDA021175_001
2NDA021983DUODOTEMERIDIAN MEDICAL TECHNOLOGIES INC2006-09-28NDA021983_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021175_001discontinuedPRALIDOXIME CHLORIDE (600MG/0.7ML), ATROPINE (2.1MG/0.7ML)INTRAMUSCULARINJECTIONFalse2002-01-17ATNAA
2NDA021983_001RXPRALIDOXIME CHLORIDE (600MG/2ML), ATROPINE (2.1MG/0.7ML)INTRAMUSCULARINJECTIONTrue2006-09-28DUODOTE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1241f42a0-1a33-40e8-8221-201767d999e5 (view SPL)DuoDote (atropine and pralidoxime chloride injection)Auto-InjectorprescriptionHuman PrescriptionU.S. Army Medical Research And Development Command (Mcmr-Rcq-Hr)MANUFACTURE2009-09-303117040620

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