Clotrimazole Topical Solution

Brand(s)
Clotrimazoil, Fortinia Solution, Fungazoil, Fungicure Solution
Category(s)
otc, prescription
SPL Type(s)
Human OTC, Human Prescription
Master SPL
Bio-Medical & Pharmaceutical Manufacturing Corporation (2015-08-27)
Oldest Current Product
1996-05-01
License(s)
ANDA, OTC MONOGRAPH FINAL
RxNORM
TOPICAL SOLUTION\CLOTRIMAZOLE
FDAOB
TOPICAL\SOLUTION\CLOTRIMAZOLE
SPL Active
TOPICAL\LIQUID\CLOTRIMAZOLE
TOPICAL\SOLUTION\CLOTRIMAZOLE
SPL Moiety
TOPICAL\LIQUID\CLOTRIMAZOLE
TOPICAL\SOLUTION\CLOTRIMAZOLE

product(s) by strength(s)

clotrimazole 10 mg/ml topical solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1379450906OTC MONOGRAPH FINALBio-Medical & Pharmaceutical Manufacturing Corporation2015-09-29CLOTRIMAZOLETOPICALLIQUID1e4e219c-1ea3-5cc2-e054-00144ff8d46c
2516722037OTC MONOGRAPH FINALTaro Pharmaceuticals U.S.A., Inc.1996-05-01CLOTRIMAZOLETOPICALSOLUTION13a14d3c-bfce-42b5-8463-4ec69e94774e
3523890160Fungicure SolutionOTC MONOGRAPH FINALAlva-Amco Pharmacal Companies, Inc2002-07-15CLOTRIMAZOLETOPICALLIQUID99ce536a-58d0-4980-8e97-29bce3c6e74d
4546330214Fortinia SolutionOTC MONOGRAPH FINALThe Podiatree Company2014-10-01CLOTRIMAZOLETOPICALSOLUTIONa003130b-77f7-4d42-8e7f-edd55176f013
5613602037OTC MONOGRAPH FINALTaro Pharmaceuticals, Inc.1996-05-01CLOTRIMAZOLETOPICALSOLUTIONc9249447-cf33-43e0-b057-c1b25bbd99b3

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000930248ANDATeva Pharmaceuticals Usa Inc1996-07-10CLOTRIMAZOLETOPICALSOLUTIONANDA073306e820037d-83cb-4f9c-940a-e846652e0603
2516721260ANDATaro Pharmaceuticals U.S.A., Inc.1996-07-29CLOTRIMAZOLETOPICALSOLUTIONANDA0745803e2041a0-8bef-4be4-b2b1-556446c4a778

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA073306CLOTRIMAZOLETEVA PHARMACEUTICALS USA INC1995-02-28ANDA073306_001
2ANDA074580CLOTRIMAZOLETARO PHARMACEUTICALS INC1996-07-29ANDA074580_001
3NDA017613LOTRIMINTrueSCHERING PLOUGH HEALTHCARE PRODUCTS INCNDA017613_001
4NDA018181MYCELEXTrueBAYER HEALTHCARE PHARMACEUTICALS INCNDA018181_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA073306_001RXCLOTRIMAZOLE (1%)TOPICALSOLUTIONFalseAT1995-02-28CLOTRIMAZOLE
2ANDA074580_001RXCLOTRIMAZOLE (1%)TOPICALSOLUTIONTrueAT1996-07-29CLOTRIMAZOLE
3NDA017613_001discontinuedCLOTRIMAZOLE (1%)TOPICALSOLUTIONFalseLOTRIMIN
4NDA018181_001discontinuedCLOTRIMAZOLE (1%)TOPICALSOLUTIONFalseMYCELEX

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
113a14d3c-bfce-42b5-8463-4ec69e94774e (view SPL)Clotrimazole Topical Solution USP,1%otcHuman OTCTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2010-12-101516722037
21e4e219c-1ea3-5cc2-e054-00144ff8d46c (view SPL)otcHuman OTCBio-Medical & Pharmaceutical Manufacturing Corporationmanufacture2015-08-271379450906
31f1b413f-278e-434f-8590-4cf731663f5c (view SPL)otcHuman OTCAlva-Amco Pharmacal Companies, Inc2013-01-141523890600
43e2041a0-8bef-4be4-b2b1-556446c4a778 (view SPL)Clotrimazole TOPICAL SOLUTION USP, 1%prescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2011-09-062516721260
555fc471c-e80c-47a0-a148-968e0b3c85ab (view SPL)Clotrimazole 1%otcHuman OTCPedifixmanufacture2014-05-071689273491
699ce536a-58d0-4980-8e97-29bce3c6e74d (view SPL)Drug FactsotcHuman OTCAlva-Amco Pharmacal Companies, Inc2011-02-243523890160
7a003130b-77f7-4d42-8e7f-edd55176f013 (view SPL)otcHuman OTCThe Podiatree Companymanufacture2014-11-141546330214
8babb5ca8-d608-4437-b35d-5133f7348d0c (view SPL)FungaZoil AdvancedotcHuman OTCPedifixmanufacture2014-06-121689273492
9c9249447-cf33-43e0-b057-c1b25bbd99b3 (view SPL)Clotrimazole Topical Solution USP,1%otcHuman OTCTaro Pharmaceuticals, Inc.MANUFACTURE2010-12-101613602037
10e820037d-83cb-4f9c-940a-e846652e0603 (view SPL)CLOTRIMAZOLE TOPICAL SOLUTION, USP 1%0248FOR DERMATOLOGIC USE ONLYNOT FOR OPHTHALMIC USEprescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2014-07-084000930248
11fd79346a-fba3-49ec-9cd3-5c00bedb4acb (view SPL)ClotrimazOil Antifungal SolutionotcHuman OTCPedifixmanufacture2013-06-191689273490
12fefa7ab3-814d-47b8-a890-a732bcb70b53 (view SPL)otcHuman OTCEduard Gerlach Gmbhmanufacture2013-02-142452640009

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