Baclofen Injection

Brand(s)
Lioresal
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Medtronic Neuromodulation (2014-11-27)
Oldest Current Product
1992-06-17
License(s)
NDA
RxNORM
INJECTION\BACLOFEN
FDAOB
INTRATHECAL\INJECTION\BACLOFEN
SPL Active
INTRATHECAL\INJECTION\BACLOFEN
SPL Moiety
INTRATHECAL\INJECTION\BACLOFEN

product(s) by strength(s)

1 ml baclofen 0.05 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1582810562LioresalNDAMedtronic Neuromodulation1996-11-07BACLOFENINTRATHECALINJECTIONNDA020075351cde63-00fa-404a-92df-cb055e991840

20 ml baclofen 0.5 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1582810560LioresalNDAMedtronic Neuromodulation1992-06-17BACLOFENINTRATHECALINJECTIONNDA020075351cde63-00fa-404a-92df-cb055e991840

20 ml baclofen 2 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1582810563LioresalNDAMedtronic Neuromodulation2003-05-08BACLOFENINTRATHECALINJECTIONNDA020075351cde63-00fa-404a-92df-cb055e991840

5 ml baclofen 2 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1582810561LioresalNDAMedtronic Neuromodulation1992-06-17BACLOFENINTRATHECALINJECTIONNDA020075351cde63-00fa-404a-92df-cb055e991840

application(s)

#idtitleapplicantapprovedapproved drugin other drug docs
1NDA020075LIORESALMEDTRONIC NEUROMODULATION1992-06-17NDA020075_001, NDA020075_002, NDA020075_003Baclofen Prefilled Syringe
2NDA022462GABLOFENMALLINCKRODT INC2010-11-19NDA022462_001, NDA022462_002, NDA022462_003, NDA022462_004Baclofen Prefilled Syringe

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1NDA020075_001RXBACLOFEN (0.5MG/ML)INTRATHECALINJECTIONTrueAP1992-06-17LIORESAL
2NDA020075_002RXBACLOFEN (2MG/ML)INTRATHECALINJECTIONTrueAP1992-06-17LIORESAL
3NDA020075_003RXBACLOFEN (0.05MG/ML)INTRATHECALINJECTIONTrueAP1996-11-07LIORESAL
4NDA022462_001RXBACLOFEN (0.05MG/ML)INTRATHECALINJECTIONFalseAP2010-11-19GABLOFEN
5NDA022462_002RXBACLOFEN (0.5MG/ML)INTRATHECALINJECTIONFalseAP2010-11-19GABLOFEN
6NDA022462_003RXBACLOFEN (2MG/ML)INTRATHECALINJECTIONFalseAP2010-11-19GABLOFEN
7NDA022462_004RXBACLOFEN (1MG/ML)INTRATHECALINJECTIONFalse2012-06-22GABLOFEN

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1351cde63-00fa-404a-92df-cb055e991840 (view SPL)prescriptionHuman PrescriptionMedtronic NeuromodulationMANUFACTURE2014-11-2710582810560, 582810561, 582810562, 582810563

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