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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 078172


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NDA 078172 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 078172
Tradename:CICLOPIROX
Applicant:Acella
Ingredient:ciclopirox
Patents:0
Pharmacology for NDA: 078172
Mechanism of ActionProtein Synthesis Inhibitors
Physiological EffectDecreased DNA Replication
Decreased Protein Synthesis
Decreased RNA Replication
Suppliers and Packaging for NDA: 078172
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CICLOPIROX ciclopirox SOLUTION;TOPICAL 078172 ANDA Acella Pharmaceuticals, LLC 42192-715 42192-715-06 1 BOTTLE in 1 CARTON (42192-715-06) / 6.6 mL in 1 BOTTLE
CICLOPIROX ciclopirox SOLUTION;TOPICAL 078172 ANDA A-S Medication Solutions 50090-6562 50090-6562-0 1 BOTTLE in 1 CARTON (50090-6562-0) / 6.6 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;TOPICALStrength8%
Approval Date:Sep 18, 2007TE:ATRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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