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NDA

CLOTRIMAZOLE | N018713 | BAYER HEALTHCARE PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Custo Pharm Inc - Citizen Petition FDA-2013-P-0028 · 4 docket documents Custo Pharm Inc filed this citizen petition requesting that the FDA designate Roxane's Clotrimazole Troche/Lozenge under ANDA 076387 as a second reference listed drug in the Orange Book, to enable filing of additional ANDAs for generic clotrimazole troche products, since the current RLD Mycelex (Bay	Other	2013-01-03	Withdrawn	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

31 trials from ClinicalTrials.gov, 22 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Comparative Efficacy Study of 10 mg Dequalinium Chloride (Fluomizin) in the Treatment of Vulvovaginal Candidiasis NCT02242695	Phase 4	Completed	Medinova AG	150	2014-11 → 2016-04
Phase I/II Randomized Study of Hydroxyurea With or Without Clotrimazole in Patients With Sickle Cell Anemia NCT00004492	Phase 1/2	Completed	University of North Carolina	20	1999-10 → 2001-09
Clinical Study to Assess the Efficacy and Safety of G238 Compared to Clotrimazole Otic Solution in the Treatment of Otomycosis NCT01993823	Phase 3	Completed	Salvat	190	2013-05 → 2014-11
Treatment of Candidal Vulvovaginitis Using Cumin Seed Extract Vaginal Suppositories.NCT03005353	Phase 2/3	Completed	Assiut University	100	2018-03-01 → 2020-01-31
A Comparison of the Safety and Effectiveness of Fluconazole or Clotrimazole in the Treatment of Fungal Infections of the Mouth and Throat in Patients With AIDS NCT00002282	N/A	Completed	Pfizer	—	—
Study of Clotrimazole and Hydroxyurea in Patients With Sickle Cell Syndromes NCT00004404	N/A	Completed	Boston Children's Hospital	20	1997-04 → 2002-09
Effectiveness Study of Ketoconazole and Betamethasone to Treat Fungal Infection and Dermatophytosis NCT02582177	Phase 3	Completed	Ache Laboratorios Farmaceuticos S.A.	125	2019-06-11 → 2020-03-24
Effectiveness of 3% Boric Acid in 70% Alcohol Versus 1% Clotrimazole Solution in Otomycosis Patients NCT01547221	N/A	Completed	Khon Kaen Hospital	120	2012-03 → 2015-04
Comparison of Two Topical Formulations Containing Clindamycin and Clotrimazole in Patients With Vaginal Infections NCT01697826	Phase 4	Completed	Dr Bharti Daswani	73	2011-04 → 2011-09
Efficacy of Slow Release Clotrimazole Varnish Treating Denture Stomatitis Comparing to Traditional Treatment of Troches NCT00835029	Phase 2	Completed	Hadassah Medical Organization	13	2009-03 → 2012-02

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain5 active DMFs7 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

ERREGIERRE SPACLOTRIMAZOLE USP-EP

DMF 63241986

FIS FABBRICA ITALIANA SINTETICI SPACLOTRIMAZOLE

DMF 75481988

OLON SPACLOTRIMAZOLE

DMF 98061992

AMOLI ORGANICS PVT LTDCLOTRIMAZOLE USP

DMF 264832012

SNJ LABS PVT LTDCLOTRIMAZOLE USP

DMF 359022021

SIFAVITOR SPAInactiveCLOTRIMAZOLE USP XX

DMF 54891984

MILES PHARMACEUTICAL DIV MILES INCInactiveCLOTRIMAZOLE 250 MG ORAL TABLETS

DMF 55571984

CUTTER BIOLOGICAL DIV MILES LABORATORIES INCInactiveCLOTRIMAZOLE

DMF 67291986

BAYER AGInactiveCLOTRIMAZOLE

DMF 67711987

CORDEN PHARMA BERGAMO SPAInactiveCLOTRIMAZOLE

DMF 107131994

SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTDInactiveCLOTRIMAZOLE

DMF 197162006

JIANGSU YUNYANG GROUP PHARMACEUTICAL CO LTDInactiveCLOTRIMAZOLE

DMF 203972007

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 15, 2002	SUPPL -19	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TROCHE/LOZENGE;ORAL | Approved: Jun 17, 1983

No patent or exclusivity listings for this strength.