pralidoxime Injection

Brand(s)
Protopam
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Baxter Healthcare Corporation (2012-06-01)
Oldest Current Product
1965-03-10
License(s)
NDA
RxNORM
INJECTION\PRALIDOXIME
FDAOB
INJECTION\INJECTION\PRALIDOXIME CHLORIDE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\PRALIDOXIME CHLORIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\PRALIDOXIME

product(s) by strength(s)

pralidoxime chloride 1000 mg injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1609770141ProtopamNDABaxter Healthcare Corporation1965-03-10PRALIDOXIME CHLORIDEINTRAMUSCULARINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA0141342741d8fd-51c2-46be-880b-99f2b20a6137

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1NDA014134PROTOPAM CHLORIDEBAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARENDA014134_001
2NDA018799PRALIDOXIME CHLORIDETrueBAXTER HEALTHCARE CORP ANESTHESIA CRITICAL CARE1982-12-13NDA018799_001
3NDA018986PRALIDOXIME CHLORIDEMERIDIAN MEDICAL TECHNOLOGIES INC1983-04-26NDA018986_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA014134_001RXPRALIDOXIME CHLORIDE (1GM/VIAL)INJECTIONTruePROTOPAM CHLORIDE
2NDA018799_001discontinuedPRALIDOXIME CHLORIDE (300MG/ML)INJECTIONFalse1982-12-13PRALIDOXIME CHLORIDE
3NDA018986_001RXPRALIDOXIME CHLORIDE (300MG/ML)INJECTIONTrue1983-04-26PRALIDOXIME CHLORIDE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12741d8fd-51c2-46be-880b-99f2b20a6137 (view SPL)PROTOPAM (pralidoxime chloride) for InjectionRx onlyprescriptionHuman PrescriptionBaxter Healthcare CorporationANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2012-06-015609770141

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