You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 13, 2025

Details for New Drug Application (NDA): 078594

✉ Email this page to a colleague

« Back to Dashboard

NDA 078594 describes CICLOPIROX, which is a drug marketed by Cosette, Fougera Pharms, Glenmark Pharms, Padagis Israel, Sun Pharma Canada, Alvogen, Glenmark Pharms Inc, Padagis Us, Actavis Mid Atlantic, Encube, Acella, Chartwell Rx, Epic Pharma Llc, Hikma, Mylan Pharms Inc, Rising, Taro Pharm Inds, and Teva Pharms, and is included in twenty-eight NDAs. It is available from fourteen suppliers. Additional details are available on the CICLOPIROX profile page.

The generic ingredient in CICLOPIROX is ciclopirox. There are ten drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ciclopirox profile page.

Summary for 078594

Tradename:	CICLOPIROX
Applicant:	Padagis Us
Ingredient:	ciclopirox
Patents:	0

Pharmacology for NDA: 078594

Mechanism of Action	Protein Synthesis Inhibitors
Physiological Effect	Decreased DNA Replication Decreased Protein Synthesis Decreased RNA Replication

Suppliers and Packaging for NDA: 078594

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CICLOPIROX	ciclopirox	SHAMPOO;TOPICAL	078594	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-401	45802-401-09	120 mL in 1 BOTTLE (45802-401-09)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SHAMPOO;TOPICAL			Strength	1%
Approval Date:	Feb 16, 2010	TE:	AT	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.