Edrophonium Injectable Solution

Brand(s)
Enlon
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mylan Institutional Llc (2013-01-31)
Oldest Current Product
2013-04-22
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\EDROPHONIUM
FDAOB
INJECTION\INJECTION\EDROPHONIUM CHLORIDE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\EDROPHONIUM CHLORIDE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\EDROPHONIUM

product(s) by strength(s)

edrophonium chloride 10 mg/ml injectable solution

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1674570190EnlonANDAMylan Institutional Llc2013-04-22EDROPHONIUM CHLORIDEINTRAMUSCULARINJECTION, SOLUTIONANDA08887398a5a2f6-3194-4202-963f-0fcd28ecadbc

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040043EDROPHONIUM CHLORIDE PRESERVATIVE FREETrueWATSON LABORATORIES INC1996-03-20ANDA040043_001
2ANDA040044EDROPHONIUM CHLORIDETrueWATSON LABORATORIES INC1996-03-20ANDA040044_001
3ANDA040131EDROPHONIUM CHLORIDETrueHOSPIRA WORLDWIDE, INC1998-02-24ANDA040131_001
4ANDA088873ENLONMYLAN INSTITUTIONAL LLC1985-08-06ANDA088873_001
5ANDA089624REVERSOLTrueORGANON USA INC1988-05-13ANDA089624_001
6NDA007959TENSILONTrueIGI LABORATORIES INCNDA007959_001, NDA007959_002

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldapprovedapplication
1ANDA040043_001discontinuedEDROPHONIUM CHLORIDE (10MG/ML)INJECTIONFalse1996-03-20EDROPHONIUM CHLORIDE PRESERVATIVE FREE
2ANDA040044_001discontinuedEDROPHONIUM CHLORIDE (10MG/ML)INJECTIONFalse1996-03-20EDROPHONIUM CHLORIDE
3ANDA040131_001discontinuedEDROPHONIUM CHLORIDE (10MG/ML)INJECTIONFalse1998-02-24EDROPHONIUM CHLORIDE
4ANDA088873_001RXEDROPHONIUM CHLORIDE (10MG/ML)INJECTIONTrue1985-08-06ENLON
5ANDA089624_001discontinuedEDROPHONIUM CHLORIDE (10MG/ML)INJECTIONFalse1988-05-13REVERSOL
6NDA007959_001discontinuedEDROPHONIUM CHLORIDE (10MG/ML)INJECTIONFalseTENSILON
7NDA007959_002discontinuedEDROPHONIUM CHLORIDE (10MG/ML)INJECTIONFalseTENSILON

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
198a5a2f6-3194-4202-963f-0fcd28ecadbc (view SPL)prescriptionHuman PrescriptionMylan Institutional Llc2013-01-317674570190

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