fomepizole Injection

Brand(s)
Antizol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Paladin Laboratories (Usa) Inc (2009-07-27)
Oldest Current Product
2007-12-14
License(s)
NDA, ANDA
RxNORM
INJECTION\FOMEPIZOLE
FDAOB
INJECTION\INJECTION\FOMEPIZOLE\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION\FOMEPIZOLE
INTRAVENOUS\INJECTION\FOMEPIZOLE
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION\FOMEPIZOLE
INTRAVENOUS\INJECTION\FOMEPIZOLE

product(s) by strength(s)

1.5 ml fomepizole 1000 mg/ml injection

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1461290200AntizolNDAPaladin Laboratories (Usa) Inc2009-07-31FOMEPIZOLEINTRAVENOUSINJECTIONNDA020696c045b5a8-b220-4f0a-a831-155b29c19454

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007813182ANDASandoz Inc2008-03-06FOMEPIZOLEINTRAVENOUSINJECTION, SOLUTIONANDA078537a306cd11-9acf-45f1-91ec-9fef2b08fdb1
2398220710ANDAX-Gen Pharmaceuticals, Inc.2007-12-14FOMEPIZOLEINTRAVENOUSINJECTION, SOLUTIONANDA078368f82eb104-ac36-4908-96fe-9d64318597e8
3674570211ANDAMylan Institutional Llc2012-10-09FOMEPIZOLEINTRAVENOUSINJECTION, SOLUTIONANDA078639911312e2-3a7c-4c97-88a8-b8d92cd12923

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA078368FOMEPIZOLELUITPOLD PHARMACEUTICALS INC2007-12-14ANDA078368_001
2ANDA078537FOMEPIZOLENAVINTA LLC2008-03-06ANDA078537_001
3ANDA078639FOMEPIZOLEMYLAN INSTITUTIONAL LLC2008-03-03ANDA078639_001
4ANDA079033FOMEPIZOLETrueMYLAN INSTITUTIONAL LLC2009-04-07ANDA079033_001
5NDA020696ANTIZOLPALADIN LABS USA INC1997-12-04p7553863, SUBSTANCENDA020696_001

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA078368_001RXFOMEPIZOLE (1.5GM/1.5ML)INJECTIONFalseAP2007-12-14FOMEPIZOLE
2ANDA078537_001RXFOMEPIZOLE (1.5GM/1.5ML)INJECTIONFalseAP2008-03-06FOMEPIZOLE
3ANDA078639_001RXFOMEPIZOLE (1.5GM/1.5ML)INJECTIONFalseAP2008-03-03FOMEPIZOLE
4ANDA079033_001discontinuedFOMEPIZOLE (1.5GM/1.5ML)INJECTIONFalse2009-04-07FOMEPIZOLE
5NDA020696_001RXFOMEPIZOLE (1.5GM/1.5ML)INJECTIONTrueAP1997-12-04ANTIZOL

patent(s)

#idexpiration dateapplication(s)
1p7553863 (view patent)2027-06-30NDA020696

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1911312e2-3a7c-4c97-88a8-b8d92cd12923 (view SPL)Fomepizole InjectionprescriptionHuman PrescriptionMylan Institutional Llc2012-09-302674570211
2a306cd11-9acf-45f1-91ec-9fef2b08fdb1 (view SPL)Rx only Sterile Caution: Must be diluted prior to use.prescriptionHuman PrescriptionSandoz IncANALYSIS, MANUFACTURE2010-06-281007813182
3c045b5a8-b220-4f0a-a831-155b29c19454 (view SPL)prescriptionHuman PrescriptionPaladin Laboratories (Usa) Incmanufacture2009-07-271461290200
4f82eb104-ac36-4908-96fe-9d64318597e8 (view SPL)Fomepizole InjectionprescriptionHuman PrescriptionX-Gen Pharmaceuticals, Inc.2013-01-074398220710

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