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SPECTAZOLE

NDA

ECONAZOLE NITRATE | N018751 | ALVOGEN 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
Citizen Petition from Lachman Consultants Services Inc FDA-2017-P-2530 · 4 docket documents Lachman Consultant Services, Inc. filed this citizen petition requesting that the FDA determine whether Alvogen Malta Operations' Spectazole (Econazole Nitrate) Cream, 1% (NDA 018751) was voluntarily withdrawn from sale for safety or effectiveness reasons, as required under 21 C.F.R. 314.161 before	505(q)	2017-04-24	Granted	Lachman Consultants Services Inc

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

Clinical Trials

8 trials from ClinicalTrials.gov, 8 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Trial of the Safety and Efficacy of EcoNail™ in the Treatment of Fungus Infections of the Great Toenail NCT00385502	Phase 2	Completed	Abeona Therapeutics, Inc	40	2006-09 → 2008-06
A Study of Econazole Foam 1% in Athlete's Foot NCT00768599	Phase 2	Completed	AmDerma	135	2008-03 → 2008-10
Therapeutic Equivalence and Safety of Two Econazole Nitrate Cream, 1% Products in Tinea Pedis NCT03129321	Phase 3	Completed	Mylan Inc.	876	2016-03-15 → 2016-11-17
Safety and Efficacy of Econazole Nitrate Foam 1% in Subjects With Tinea Pedis NCT01353976	Phase 3	Completed	AmDerma	264	2011-05 → 2012-08
Safety and Efficacy of Econazole Nitrate Foam 1% and Foam Vehicle in Subjects With Tinea Pedis NCT01358240	Phase 3	Completed	AmDerma	336	2011-06 → 2012-08
Comparative PK Study of Econazole Nitrate Foam and Econazole Nitrate Cream in Subjects With Interdigital Tinea Pedis Aged 12 Years to Less Than 18 Years NCT01696799	Phase 2	Completed	AmDerma	42	2011-09 → 2012-08
Tolerability and Pharmacokinetic Study of Econazole Nitrate and Benzydamine HCl Intravaginal Cream NCT02713893	Phase 1	Completed	Aziende Chimiche Riunite Angelini Francesco S.p.A	48	2015-09 → 2016-06-15
Tolerability and Pharmacokinetic Study of Econazole Nitrate Plus Benzydamine HCl Vaginal Pessary NCT02720783	Phase 1	Completed	Aziende Chimiche Riunite Angelini Francesco S.p.A	49	2016-03-04 → 2016-10-12

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

API Supply Chain4 active DMFs6 inactive

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

FDC LTDECONAZOLE NITRATE USP

DMF 104561993

YUNG ZIP CHEMICAL IND CO LTDECONAZOLE NITRATE

DMF 111401994

OLON SPAECONAZOLE NITRATE

DMF 128571998

PMC ISOCHEMECONAZOLE NITRATE

DMF 268722013

CILAG CHEMIE AGInactiveECONAZOLE NITRATE

DMF 28771977

ERREGIERRE SPAInactiveECONAZOLE NITRATE

DMF 68691987

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPAInactiveECONAZOLE NITRATE

DMF 75471988

GUANGDONG PHARMACEUTICAL FACTORYInactiveECONAZOLE NITRATE

DMF 113031994

GUFIC BIOSCIENCES LTDInactiveECONAZOLE NITRATE USP

DMF 127991997

SIFAVITOR SRLInactiveECONAZOLE

DMF 142371999

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jan 22, 2020	SUPPL -25	View Letter (PDF)
Apr 2, 2014	SUPPL -23	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Dec 23, 1982

No patent or exclusivity listings for this strength.