Metronidazole Prefilled Applicator

Brand(s)
Nuvessa
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Actavis Pharma, Inc. (2015-01-01)
Oldest Current Product
2015-01-01
License(s)
NDA
RxNORM
PREFILLED APPLICATOR\METRONIDAZOLE
FDAOB
VAGINAL\GEL\METRONIDAZOLE
SPL Active
VAGINAL\GEL\METRONIDAZOLE
SPL Moiety
VAGINAL\GEL\METRONIDAZOLE

product(s) by strength(s)

5000 mg metronidazole 0.013 mg/mg prefilled applicator

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1525440157NuvessaNDAActavis Pharma, Inc.2015-01-01METRONIDAZOLEVAGINALGELNDA205223520c3783-b0fa-407b-8c4a-3830af32b8fa

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drugin other drug docs
1ANDA077264METRONIDAZOLETOLMAR INC2006-10-31ANDA077264_001Metronidazole Vaginal Gel
2NDA020208METROGEL-VAGINALMEDICIS PHARMACEUTICAL CORP1992-08-17NDA020208_001Metronidazole Vaginal Gel
3NDA021806VANDAZOLETEVA PHARMACEUTICALS USA2005-05-20p7456207, SUBSTANCENDA021806_001Metronidazole Vaginal Gel
4NDA205223NUVESSAACTAVIS LABORATORIES UT INC2014-03-24p8946276, TREATMENT OF BACTERIAL VAGINOSIS WITH METRONIDAZOLE GEL
p8877792, SUBSTANCE
p7893097, SUBSTANCE
p8658678, TREATMENT OF BACTERIAL VAGINOSIS
NEW PRODUCT [2017-03-24]NDA205223_001Metronidazole Vaginal Gel

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA077264_001RXMETRONIDAZOLE (0.75%)VAGINALGELFalseAB2006-10-31METRONIDAZOLE
2NDA020208_001RXMETRONIDAZOLE (0.75%)VAGINALGELTrueAB1992-08-17METROGEL-VAGINAL
3NDA021806_001RXMETRONIDAZOLE (0.75%)VAGINALGELFalseBX2005-05-20VANDAZOLE
4NDA205223_001RXMETRONIDAZOLE (1.3%)VAGINALGELTrue2014-03-24NUVESSA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p7456207 (view patent)2024-09-22NDA021806Metronidazole Vaginal Gel
2p7893097 (view patent)2028-02-19NDA205223Metronidazole Vaginal Gel
3p8658678 (view patent)2028-06-27NDA205223Metronidazole Vaginal Gel
4p8877792 (view patent)2028-02-02NDA205223Metronidazole Vaginal Gel
5p8946276 (view patent)2032-06-28NDA205223Metronidazole Vaginal Gel

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1520c3783-b0fa-407b-8c4a-3830af32b8fa (view SPL)These highlights do not include all the information needed to useNUVESSATM (metronidazole vaginal gel 1.3%) safely and effectively. See full prescribing information for NUVESSA. NUVESSATM (metronidazole vaginal gel 1.3%) Initial U.S. Approval: 1963prescriptionHuman PrescriptionActavis Pharma, Inc.2015-01-012525440157

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