Atropine / Edrophonium Injection

Brand(s)
Enlon-Plus
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Institutional Llc (2013-01-31)
Oldest Current Product
1991-11-06
License(s)
NDA
RxNORM
INJECTION\ATROPINE:EDROPHONIUM
FDAOB
INJECTION\INJECTION\ATROPINE SULFATE: EDROPHONIUM CHLORIDE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\ATROPINE SULFATE: EDROPHONIUM CHLORIDE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\ATROPINE: EDROPHONIUM

product(s) by strength(s)

5 ml atropine sulfate 0.14 mg/ml / edrophonium chloride 10 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1674570192Enlon-PlusNDAMylan Institutional Llc1991-11-06ATROPINE SULFATE, EDROPHONIUM CHLORIDEINTRAVENOUSINJECTION, SOLUTIONNDA019678358336e5-3628-49ec-9134-6ec8c4ea733a

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1NDA019677ENLON-PLUSTrueMYLAN INSTITUTIONAL LLC1991-11-06NDA019677_001
2NDA019678ENLON-PLUSMYLAN INSTITUTIONAL LLC1991-11-06NDA019678_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1NDA019677_001discontinuedEDROPHONIUM CHLORIDE (10MG/ML), ATROPINE SULFATE (0.14MG/ML)INJECTIONFalse1991-11-06ENLON-PLUS
2NDA019678_001RXEDROPHONIUM CHLORIDE (10MG/ML), ATROPINE SULFATE (0.14MG/ML)INJECTIONTrue1991-11-06ENLON-PLUS

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1358336e5-3628-49ec-9134-6ec8c4ea733a (view SPL)prescriptionHuman PrescriptionMylan Institutional Llc2013-01-317674570192

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