terconazole Vaginal Suppository

Brand(s)
Terazol 3, Zazole
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Janssen Pharmaceuticals, Inc. (2014-07-29)
Oldest Current Product
1988-05-24
License(s)
NDA, ANDA
RxNORM
VAGINAL SUPPOSITORY\TERCONAZOLE
FDAOB
VAGINAL\SUPPOSITORY\TERCONAZOLE
SPL Active
VAGINAL\SUPPOSITORY\TERCONAZOLE
SPL Moiety
VAGINAL\SUPPOSITORY\TERCONAZOLE

product(s) by strength(s)

terconazole 80 mg vaginal suppository

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504580531Terazol 3NDAJanssen Pharmaceuticals, Inc.1988-05-24TERCONAZOLEVAGINALSUPPOSITORYNDA0196416f2626b3-6053-4f7a-bc5d-78e30d983f90

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007130552ANDAG&W Laboratories, Inc.2015-09-25TERCONAZOLEVAGINALSUPPOSITORYANDA07755338cd1718-6b3c-415d-a17f-7b399adb0ba2
2458020717ANDAPerrigo New York Inc2006-08-28TERCONAZOLEVAGINALSUPPOSITORYANDA077149207e9cf2-e8ec-43d7-9c11-46283c9cdb37
3516721330ANDATaro Pharmaceuticals U.S.A., Inc.2007-03-09TERCONAZOLEVAGINALSUPPOSITORYANDA077553b4f50a11-bd39-4023-9145-2da60f6b085f

invalid application product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004620348ZazoleANDAPharmaderm, A Division Of Nycomed Us Inc.2006-07-12TERCONAZOLEVAGINALSUPPOSITORYANDA076850b5aa5021-2a1b-4d21-a6b0-821ea1f9e2d0

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076850TERCONAZOLETrueFOUGERA PHARMACEUTICALS INC2006-07-12ANDA076850_001
2ANDA077149TERCONAZOLEPERRIGO NEW YORK INC2006-03-17ANDA077149_001
3ANDA077553TERCONAZOLETARO PHARMACEUTICALS USA INC2007-03-09ANDA077553_001
4NDA019641TERAZOL 3JANSSEN PHARMACEUTICALS INC1988-05-24NDA019641_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076850_001discontinuedTERCONAZOLE (80MG)VAGINALSUPPOSITORYFalse2006-07-12TERCONAZOLE
2ANDA077149_001RXTERCONAZOLE (80MG)VAGINALSUPPOSITORYFalseAB2006-03-17TERCONAZOLE
3ANDA077553_001RXTERCONAZOLE (80MG)VAGINALSUPPOSITORYFalseAB2007-03-09TERCONAZOLE
4NDA019641_001RXTERCONAZOLE (80MG)VAGINALSUPPOSITORYTrueAB1988-05-24TERAZOL 3

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1207e9cf2-e8ec-43d7-9c11-46283c9cdb37 (view SPL)Terconazole Vaginal Suppositories, 80 mgprescriptionHuman PrescriptionPerrigo New York Inc2015-03-313458020717
238cd1718-6b3c-415d-a17f-7b399adb0ba2 (view SPL)Terconazole Vaginal Suppositories 80 mgprescriptionHuman PrescriptionG&W Laboratories, Inc.MANUFACTURE2015-09-111007130552
361eab575-94e4-41cb-8045-af73424bb316 (view SPL)TERAZOL 7 VAGINAL CREAM 0.4%(terconazole ) TERAZOL 3 VAGINAL CREAM 0.8%(terconazole) TERAZOL 3 VAGINAL SUPPOSITORIES 80mg(terconazole)prescriptionHuman PrescriptionOrtho-Mcneil Janssen Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2010-09-159000625350, 000625351, 000625356terconazole Vaginal Cream
46f2626b3-6053-4f7a-bc5d-78e30d983f90 (view SPL)TERAZOL 7 VAGINAL CREAM 0.4% (terconazole) TERAZOL 3 VAGINAL CREAM 0.8% (terconazole) TERAZOL 3 VAGINAL SUPPOSITORIES 80 MG (terconazole)prescriptionHuman PrescriptionJanssen Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE2014-07-294504580531, 504580535, 504580536terconazole Vaginal Cream
5b4f50a11-bd39-4023-9145-2da60f6b085f (view SPL)Terconazole Vaginal Suppositories 80 mgprescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2014-09-023516721330
6b5aa5021-2a1b-4d21-a6b0-821ea1f9e2d0 (view SPL)Zazole Vaginal Suppositories(terconazole vaginal suppositories, 80 mg)prescriptionHuman PrescriptionPharmaderm, A Division Of Nycomed Us Inc.2013-03-042004620348

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