tioconazole Prefilled Applicator

Brand(s)
Vagistat-1
Category(s)
otc
SPL Type(s)
Human OTC
Master SPL
Novartis Consumer Health, Inc. (2014-09-29)
Oldest Current Product
1997-02-11
License(s)
NDA, ANDA
RxNORM
PREFILLED APPLICATOR\TIOCONAZOLE
FDAOB
VAGINAL\OINTMENT\TIOCONAZOLE
SPL Active
VAGINAL\OINTMENT\TIOCONAZOLE
SPL Moiety
VAGINAL\OINTMENT\TIOCONAZOLE

product(s) by strength(s)

300 mg tioconazole 0.065 mg/mg prefilled applicator

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000672090Vagistat-1NDANovartis Consumer Health, Inc.1997-02-11TIOCONAZOLEVAGINALOINTMENTNDA02067678ebebac-fc6a-42b9-a402-8a830c51a043

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003630426ANDAWalgreens2007-12-19TIOCONAZOLEVAGINALOINTMENTANDA075915c05a4413-8a5f-4b91-9c22-b1db785e8e9e
2118220426ANDARite Aid2007-12-13TIOCONAZOLEVAGINALOINTMENTANDA075915c13c4087-8ca3-4e08-a7af-54efd21c9d30
3243850374ANDAGood Neighbor Pharmacy2008-02-20TIOCONAZOLEVAGINALOINTMENTANDA0759159dbf539b-9f57-4efa-a235-206c9eea4287
4368000426ANDATop Care (Topco Associates Llc)2008-03-03TIOCONAZOLEVAGINALOINTMENTANDA075915fce06160-2098-4ac1-9cc3-a584d4f5a51d
5372050296ANDACardinal Health2008-04-03TIOCONAZOLEVAGINALOINTMENTANDA075915e26d72cf-4c99-4dee-8212-c63b9649525a
6412500426ANDAMeijer Distribution, Inc2008-01-09TIOCONAZOLEVAGINALOINTMENTANDA0759157f0b0a4a-f8b5-4d86-afad-fe7e7eee2a31
7490350426ANDAWalmart2007-11-01TIOCONAZOLEVAGINALOINTMENTANDA0759156b3ee10a-d945-41f4-bbb5-ff2e2fdcd22c
8493480508ANDASunmark2007-12-18TIOCONAZOLEVAGINALOINTMENTANDA075915adf8532d-e0ef-4623-8a1e-0a51c37d77c2
9497380426ANDAKmart Corp2011-07-11TIOCONAZOLEVAGINALOINTMENTANDA07591554b2355b-84c4-45a6-854e-f2c2501725e8
10553160426ANDADza Brands,2008-04-06TIOCONAZOLEVAGINALOINTMENTANDA075915bf37da92-f67b-46b3-92bb-53cf5596c2ae

4600 mg tioconazole 0.065 mg/mg prefilled applicator

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1497380061ANDAKmart Corp2014-12-26TIOCONAZOLEVAGINALOINTMENTANDA075915f16e266f-cd94-461c-ad3d-77bde3d626fb

application(s)

#idtitleapplicantapprovedapproved drugin other drug docs
1ANDA075915TIOCONAZOLEL PERRIGO CO2001-11-21ANDA075915_001tioconazole Vaginal Ointment
2NDA020676VAGISTAT-1NOVARTIS CONSUMER HEALTH INC1997-02-11NDA020676_001tioconazole Vaginal Ointment

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA075915_001OTCTIOCONAZOLE (6.5%)VAGINALOINTMENTFalse2001-11-21TIOCONAZOLE
2NDA020676_001OTCTIOCONAZOLE (6.5%)VAGINALOINTMENTTrue1997-02-11VAGISTAT-1

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
154b2355b-84c4-45a6-854e-f2c2501725e8 (view SPL)Kmart Corporation Tioconazole-1 Drug FactsotcHuman OTCKmart Corp2011-12-061497380426
26b3ee10a-d945-41f4-bbb5-ff2e2fdcd22c (view SPL)Wal-Mart Tioconazole 1 Day Drug FactsotcHuman OTCWalmart2011-12-051490350426
378ebebac-fc6a-42b9-a402-8a830c51a043 (view SPL)Drug FactsotcHuman OTCNovartis Consumer Health, Inc.2014-09-291000672090
47f0b0a4a-f8b5-4d86-afad-fe7e7eee2a31 (view SPL)Meijer Distribution, Inc. Tioconazole 1 Drug FactsotcHuman OTCMeijer Distribution, Inc2015-04-102412500426
59dbf539b-9f57-4efa-a235-206c9eea4287 (view SPL)Amerisource Bergen Tioconazole 1 Drug FactsotcHuman OTCGood Neighbor Pharmacy2012-03-122243850374
6adf8532d-e0ef-4623-8a1e-0a51c37d77c2 (view SPL)McKesson Tioconazole 1 Drug FactsotcHuman OTCSunmark2009-11-161493480508
7bf37da92-f67b-46b3-92bb-53cf5596c2ae (view SPL)DZA Brands, LLC Tioconazole 1 Drug FactsotcHuman OTCDza Brands,2015-01-222553160426
8c05a4413-8a5f-4b91-9c22-b1db785e8e9e (view SPL)Walgreen Co. Tioconazole 1 Ointment Drug FactsotcHuman OTCWalgreens2015-07-282003630426
9c13c4087-8ca3-4e08-a7af-54efd21c9d30 (view SPL)Rite Aid Corporation Tioconazole 1 Drug FactsotcHuman OTCRite Aid2013-11-252118220426
10e26d72cf-4c99-4dee-8212-c63b9649525a (view SPL)Cardinal Health Tioconastat 1 Drug FactsotcHuman OTCCardinal Health2009-11-161372050296
11f16e266f-cd94-461c-ad3d-77bde3d626fb (view SPL)Kmart Corporation Tioconazole Treatment Drug FactsotcHuman OTCKmart Corp2014-12-291497380061
12fce06160-2098-4ac1-9cc3-a584d4f5a51d (view SPL)Topco Tioconazole 1 Drug FactsotcHuman OTCTop Care (Topco Associates Llc)2009-11-161368000426

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