Miconazole Vaginal Suppository

Category(s)
otc, prescription
SPL Type(s)
Human OTC, Human Prescription
Master SPL
Actavis Pharma, Inc. (2009-03-14)
Oldest Current Product
1993-11-19
License(s)
ANDA
RxNORM
VAGINAL SUPPOSITORY\MICONAZOLE
FDAOB
VAGINAL\SUPPOSITORY\MICONAZOLE NITRATE
SPL Active
VAGINAL\SUPPOSITORY\MICONAZOLE NITRATE
SPL Moiety
VAGINAL\SUPPOSITORY\MICONAZOLE

product(s) by strength(s)

miconazole nitrate 100 mg vaginal suppository

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004721736ANDAActavis Pharma, Inc.1993-11-19MICONAZOLE NITRATEVAGINALSUPPOSITORYANDA0735073d3968de-f298-4b59-acfa-1caf1e4631c1
2493480833ANDASunmark2011-12-09MICONAZOLE NITRATEVAGINALSUPPOSITORYANDA07350789132802-beb1-42f4-8da4-39918fc5c4dd

miconazole nitrate 200 mg vaginal suppository

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004721738ANDAActavis Pharma, Inc.2002-09-03MICONAZOLE NITRATEVAGINALSUPPOSITORYANDA073508aa9e250b-f317-42cb-b8d2-e85de56f4ef7

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA073507MICONAZOLE NITRATEACTAVIS MID ATLANTIC LLC1993-11-19ANDA073507_001
2ANDA073508MICONAZOLE NITRATEACTAVIS MID ATLANTIC LLC1993-11-19ANDA073508_001
3ANDA074395MICONAZOLE NITRATEL PERRIGO CO1997-03-20ANDA074395_001
4ANDA074414MICONAZOLE NITRATEG AND W LABORATORIES INC1997-04-30ANDA074414_001
5NDA018520MONISTAT 7MEDTECH PRODUCTS INC1991-02-15NDA018520_002
6NDA018888MONISTAT 3MEDTECH PRODUCTS INC1984-08-15NDA018888_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA073507_001OTCMICONAZOLE NITRATE (100MG)VAGINALSUPPOSITORYFalse1993-11-19MICONAZOLE NITRATE
2ANDA073508_001RXMICONAZOLE NITRATE (200MG)VAGINALSUPPOSITORYFalseAB1993-11-19MICONAZOLE NITRATE
3ANDA074395_001OTCMICONAZOLE NITRATE (100MG)VAGINALSUPPOSITORYTrue1997-03-20MICONAZOLE NITRATE
4ANDA074414_001OTCMICONAZOLE NITRATE (100MG)VAGINALSUPPOSITORYFalse1997-04-30MICONAZOLE NITRATE
5NDA018520_002OTCMICONAZOLE NITRATE (100MG)VAGINALSUPPOSITORYTrue1991-02-15MONISTAT 7
6NDA018888_001RXMICONAZOLE NITRATE (200MG)VAGINALSUPPOSITORYTrueAB1984-08-15MONISTAT 3

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
13d3968de-f298-4b59-acfa-1caf1e4631c1 (view SPL)Miconazole Nitrate Vaginal SuppositoriesotcHuman OTCActavis Pharma, Inc.2014-06-254004721736
289132802-beb1-42f4-8da4-39918fc5c4dd (view SPL)Miconazole 7 Vaginal SuppositoriesotcHuman OTCSunmark2014-06-253493480833
3aa9e250b-f317-42cb-b8d2-e85de56f4ef7 (view SPL)Miconazole Nitrate Vaginal Suppositories USP, 200 mgprescriptionHuman PrescriptionActavis Pharma, Inc.MANUFACTURE2009-03-142004721738

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