Baclofen Prefilled Syringe

Brand(s)
Gablofen
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mallinckrodt Inc (Brand Pharmaceuticals) (2015-02-02)
Oldest Current Product
2010-11-19
License(s)
NDA
RxNORM
PREFILLED SYRINGE\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 prefilled syringe

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1459450151GablofenNDAMallinckrodt Inc (Brand Pharmaceuticals)2010-11-19BACLOFENINTRATHECALINJECTIONNDA0224620a50560d-d053-4cb2-8160-8ee35179c0ee

application(s)

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

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)

#idtitlecategorytypelabelerlast updateversionproduct(s)
10a50560d-d053-4cb2-8160-8ee35179c0ee (view SPL)These highlights do not include all the information needed to use GABLOFEN safely and effectively. See full prescribing information for GABLOFEN. GABLOFEN (baclofen injection), for intrathecal use Initial U.S. Approval: 1992prescriptionHuman PrescriptionMallinckrodt Inc (Brand Pharmaceuticals)2015-02-0223459450151, 459450155, 459450156, 459450157

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