Orphenadrine Injectable Solution

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Akorn (2012-06-08)
Oldest Current Product
2006-10-17
License(s)
ANDA
RxNORM
INJECTABLE SOLUTION\ORPHENADRINE
FDAOB
INJECTION\INJECTION\ORPHENADRINE CITRATE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, SOLUTION\ORPHENADRINE CITRATE
INTRAMUSCULAR\INJECTION\ORPHENADRINE CITRATE
SPL Moiety
INTRAMUSCULAR\INJECTION, SOLUTION\ORPHENADRINE
INTRAMUSCULAR\INJECTION\ORPHENADRINE

product(s) by strength(s)

orphenadrine citrate 30 mg/ml injectable solution

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005913222ANDAWatson Laboratories, Inc.2010-07-08ORPHENADRINE CITRATEINTRAMUSCULARINJECTIONANDA084779aec8ad3a-f717-4e74-b7b9-19debdaad79a
2174780538ANDAAkorn2006-10-17ORPHENADRINE CITRATEINTRAMUSCULARINJECTIONANDA04048456bc8e4a-6771-476d-95e8-e4ef2d869cb2
3250210651ANDASagent Pharmaceuticals2011-10-01ORPHENADRINE CITRATEINTRAMUSCULARINJECTION, SOLUTIONANDA090585c8d8596a-b81f-4b83-a2f3-a55922ca4a82

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040463ORPHENADRINE CITRATEEUROHEALTH INTERNATIONAL SARL2003-03-04ANDA040463_001
2ANDA040484ORPHENADRINE CITRATEAKORN INC2006-05-24ANDA040484_001
3ANDA084779ORPHENADRINE CITRATEWATSON LABORATORIES INC1982-03-15ANDA084779_001
4ANDA087062ORPHENADRINE CITRATETrueWATSON LABORATORIES INCANDA087062_001
5ANDA090585ORPHENADRINE CITRATESAGENT PHARMACEUTICALS INC2011-08-30ANDA090585_001
6NDA013055NORFLEXTrueIGI LABORATORIES INCNDA013055_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA040463_001RXORPHENADRINE CITRATE (30MG/ML)INJECTIONFalseAP2003-03-04ORPHENADRINE CITRATE
2ANDA040484_001RXORPHENADRINE CITRATE (30MG/ML)INJECTIONTrueAP2006-05-24ORPHENADRINE CITRATE
3ANDA084779_001RXORPHENADRINE CITRATE (30MG/ML)INJECTIONFalseAP1982-03-15ORPHENADRINE CITRATE
4ANDA087062_001discontinuedORPHENADRINE CITRATE (30MG/ML)INJECTIONFalseORPHENADRINE CITRATE
5ANDA090585_001RXORPHENADRINE CITRATE (30MG/ML)INJECTIONFalseAP2011-08-30ORPHENADRINE CITRATE
6NDA013055_001discontinuedORPHENADRINE CITRATE (30MG/ML)INJECTIONFalseNORFLEX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
156bc8e4a-6771-476d-95e8-e4ef2d869cb2 (view SPL)ORPHENADRINE CITRATE INJECTION, USPprescriptionHuman PrescriptionAkornANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2012-06-081174780538
2aec8ad3a-f717-4e74-b7b9-19debdaad79a (view SPL)ORPHENADRINE CITRATE INJECTION USP Rx onlyprescriptionHuman PrescriptionWatson Laboratories, Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2010-07-214005913222
3c8d8596a-b81f-4b83-a2f3-a55922ca4a82 (view SPL)Orphenadrine Citrate Injection, USP(For IV or IM Use)prescriptionHuman PrescriptionSagent Pharmaceuticals2009-12-232250210651

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