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Last Updated: January 19, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020519

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NDA 020519 describes CICLOPIROX, which is a drug marketed by Acp Nimble, Fougera Pharms, Glenmark Pharms, Perrigo Israel, Taro, Cnty Line Pharms, Glenmark Generics, Paddock Llc, Actavis Mid Atlantic, Perrigo Co, Teligent Pharma Inc, Acella, Akorn, Anda Repository, Hi Tech Pharma, Mylan Pharms Inc, Novast Labs, Perrigo New York, 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. Eighteen suppliers are listed for this compound. Additional details are available on the ciclopirox profile page.
Summary for 020519
Tradename:CICLOPIROX
Applicant:Cnty Line Pharms
Ingredient:ciclopirox
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 020519
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CICLOPIROX ciclopirox GEL;TOPICAL 020519 NDA Alvogen Inc. 47781-530 47781-530-73 1 TUBE in 1 CARTON (47781-530-73) > 30 g in 1 TUBE
CICLOPIROX ciclopirox GEL;TOPICAL 020519 NDA Alvogen Inc. 47781-530 47781-530-84 1 TUBE in 1 CARTON (47781-530-84) > 45 g in 1 TUBE
Paragraph IV (Patent) Challenges for 020519
Tradename Dosage Ingredient NDA Submissiondate
CICLOPIROX GEL;TOPICAL ciclopirox 020519 2006-05-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength0.77%
Approval Date:Jul 21, 1997TE:ABRLD:Yes

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