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PENLAC

NDA

CICLOPIROX | N021022 | VALEANT INTERNATIONAL BERMUDA

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain7 active DMFs4 inactive

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

OLON SPACICLOPIROX OLAMINE

DMF 113891995

ERREGIERRE SPACICLOPIROX OLAMINE USP-PH.EUR.

DMF 163522003

ERREGIERRE SPACICLOPIROX USP-EP

DMF 163532002

PCASCICLOPIROX

DMF 170072003

OLON SPACICLOPIROX

DMF 171562004

INTERQUIM SACICLOPIROX USP

DMF 189292005

KUMAR ORGANIC PRODUCTS LIMITEDCICLOPIROX OLAMINE

DMF 423042025

EUROAPI GERMANY GMBHInactiveCICLOPIROX

DMF 146271999

SANOFI AVENTIS DEUTSCHLAND GMBHInactiveCICLOPIROX OLAMINE

DMF 146331999

PIERRE FABRE MEDICAMENTInactiveCICLOPIROX

DMF 171992004

SYNKEM SASInactiveCICLOPIROX

DMF 173472004

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Dec 8, 2004	SUPPL -4	View Letter (PDF)
Dec 24, 2003	SUPPL -3	View Letter (PDF)
Jun 22, 2003	SUPPL -2	View Letter (PDF)
Dec 17, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;TOPICAL | Approved: Dec 17, 1999

No patent or exclusivity listings for this strength.